[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886]

[Page 407-428]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 886--OPHTHALMIC DEVICES

                      Subpart A--General Provisions

Sec.
886.1  Scope.
886.3  Effective dates of requirement for premarket approval.
886.9  Limitations of exemptions from section 510(k) of the act.

                      Subpart B--Diagnostic Devices

886.1040  Ocular esthesiometer.
886.1050  Adaptometer (biophotometer).
886.1070  Anomaloscope.
886.1090  Haidlinger brush.
886.1120  Ophthalmic camera.
886.1140  Ophthalmic chair.
886.1150  Visual acuity chart.
886.1160  Color vision plate illuminator.
886.1170  Color vision tester.
886.1190  Distometer.
886.1200  Optokinetic drum.
886.1220  Corneal electrode.
886.1250  Euthyscope.
886.1270  Exophthalmometer.
886.1290  Fixation device.
886.1300  Afterimage flasher.
886.1320  Fornixscope.
886.1330  Amsler grid.
886.1340  Haploscope.
886.1350  Keratoscope.
886.1360  Visual field laser instrument.
886.1375  Bagolini lens.
886.1380  Diagnostic condensing lens.
886.1385  Polymethylmethacrylate (PMMA) diagnostic contact lens.
886.1390  Flexible diagnostic Fresnel lens.
886.1395  Diagnostic Hruby fundus lens.
886.1400  Maddox lens.
886.1405  Ophthalmic trial lens set.
886.1410  Ophthalmic trial lens clip.
886.1415  Ophthalmic trial lens frame.
886.1420  Ophthalmic lens gauge.
886.1425  Lens measuring instrument.
886.1430  Ophthalmic contact lens radius measuring device.
886.1435  Maxwell spot.
886.1450  Corneal radius measuring device.
886.1460  Stereopsis measuring instrument.
886.1500  Headband mirror.
886.1510  Eye movement monitor.
886.1570  Ophthalmoscope.
886.1605  Perimeter.
886.1630  AC-powered photostimulator.
886.1640  Ophthalmic preamplifier.
886.1650  Ophthalmic bar prism.
886.1655  Ophthalmic Fresnel prism.
886.1660  Gonioscopic prism.
886.1665  Ophthalmic rotary prism.
886.1670  Ophthalmic isotope uptake probe.
886.1680  Ophthalmic projector.
886.1690  Pupillograph.
886.1700  Pupillometer.
886.1750  Skiascopic rack.
886.1760  Ophthalmic refractometer.
886.1770  Manual refractor.
886.1780  Retinoscope.
886.1790  Nearpoint ruler.
886.1800  Schirmer strip.
886.1810  Tangent screen (campimeter).
886.1840  Simulatan (including crossed cylinder).
886.1850  AC-powered slitlamp biomicroscope.
886.1860  Ophthalmic instrument stand.
886.1870  Stereoscope.
886.1880  Fusion and stereoscopic target.
886.1905  Nystagmus tape.
886.1910  Spectacle dissociation test system.
886.1930  Tonometer and accessories.
886.1940  Tonometer sterilizer.
886.1945  Transilluminator.

                          Subpart C  [Reserved]

                      Subpart D--Prosthetic Devices

886.3100  Ophthalmic tantalum clip.
886.3130  Ophthalmic conformer.
886.3200  Artificial eye.
886.3300  Absorbable implant (scleral buckling method).

[[Page 408]]

886.3320  Eye sphere implant.
886.3340  Extraocular orbital implant.
886.3400  Keratoprosthesis.
886.3600  Intraocular lens.
886.3800  Scleral shell.
886.3920  Eye valve implant.

                       Subpart E--Surgical Devices

886.4070  Powered corneal burr.
886.4100  Radiofrequency electrosurgical cautery apparatus.
886.4115  Thermal cautery unit.
886.4150  Vitreous aspiration and cutting instrument.
886.4170  Cryophthalmic unit.
886.4230  Ophthalmic knife test drum.
886.4250  Ophthalmic electrolysis unit.
886.4270  Intraocular gas.
886.4275  Intraocular fluid.
886.4280  Intraocular pressure measuring device.
886.4300  Intraocular lens guide.
886.4335  Operating headlamp.
886.4350  Manual ophthalmic surgical instrument.
886.4360  Ocular surgery irrigation device.
886.4370  Keratome.
886.4390  Ophthalmic laser.
886.4392  Nd:YAG laser for posterior capsulotomy.
886.4400  Electronic metal locator.
886.4440  AC-powered magnet.
886.4445  Permanent magnet.
886.4570  Ophthalmic surgical marker.
886.4610  Ocular pressure applicator.
886.4670  Phacofragmentation system.
886.4690  Ophthalmic photocoagulator.
886.4750  Ophthalmic eye shield.
886.4770  Ophthalmic operating spectacles (loupes).
886.4790  Ophthalmic sponge.
886.4855  Ophthalmic instrument table.

                     Subpart F--Therapeutic Devices

886.5100  Ophthalmic beta radiation source.
886.5120  Low-power binocular loupe.
886.5420  Contact lens inserter/remover.
886.5540  Low-vision magnifier.
886.5600  Ptosis crutch.
886.5800  Ophthalmic bar reader.
886.5810  Ophthalmic prism reader.
886.5820  Closed-circuit television reading system.
886.5840  Magnifying spectacles.
886.5842  Spectacle frame.
886.5844  Prescription spectacle lens.
886.5850  Sunglasses (nonprescription).
886.5870  Low-vision telescope.
886.5900  Electronic vision aid.
886.5910  Image intensification vision aid.
886.5915  Optical vision aid.
886.5916  Rigid gas permeable contact lens.
886.5918  Rigid gas permeable contact lens care products.
886.5925  Soft (hydrophilic) contact lens.
886.5928  Soft (hydrophilic) contact lens care products.
886.5933  [Reserved]

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    Source:  52 FR 33355, Sept. 2, 1987, unless otherwise noted.

                      Subpart A--General Provisions

Sec. 886.1  Scope.

    (a) This part sets forth the classification of ophthalmic devices 
intended for human use that are in commercial distribution.
    (b) The identification of a device in a regulation in this part is 
not a precise description of every device that is, or will be, subject 
to the regulation. A manufacturer who submits a premarket notification 
submission for a device under part 807 cannot show merely that the 
device is accurately described by the section title and identification 
provision of a regulation in this part but shall state why the device is 
substantially equivalent to other devices, as required by Sec. 807.87.
    (c) To avoid duplicative listings, an ophthalmic device that has two 
or more types of uses (e.g., used both as a diagnostic device and as a 
therapeutic device) is listed in one subpart only.
    (d) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.

Sec. 886.3  Effective dates of requirement for premarket approval.

    A device included in this part that is classified into class III 
(premarket approval) shall not be commercially distributed after the 
date shown in the regulation classifying the device unless the 
manufacturer has an approval under section 515 of the act (unless an 
exemption has been granted under section 520(g)(2) of the act). An 
approval under section 515 of the act consists of FDA's issuance of an 
order approving an application for premarket approval (PMA) for the 
device or declaring completed a product development protocol (PDP) for 
the device.
    (a) Before FDA requires that a device commercially distributed 
before the enactment date of the amendments, or

[[Page 409]]

a device that has been found substantially equivalent to such a device, 
has an approval under section 515 of the act, FDA must promulgate a 
regulation under section 515(b) of the act requiring such approval, 
except as provided in paragraphs (b) and (c) of this section. Such a 
regulation under section 515(b) of the act shall not be effective during 
the grace period ending on the 90th day after its promulgation or on the 
last day of the 30th full calendar month after the regulation that 
classifies the device into class III is effective, whichever is later. 
See section 501(f)(2)(B) of the act. Accordingly, unless an effective 
date of the requirement for premarket approval is shown in the 
regulation for a device classified into class III in this part, the 
device may be commercially distributed without FDA's issuance of an 
order approving a PMA or declaring completed a PDP for the device. If 
FDA promulgates a regulation under section 515(b) of the act requiring 
premarket approval for a device, section 501(f)(1)(A) of the act applies 
to the device.
    (b) Any new, not substantially equivalent, device introduced into 
commercial distribution on or after May 28, 1976, including a device 
formerly marketed that has been substantially altered, is classified by 
statute (section 513(f) of the act) into class III without any grace 
period and FDA must have issued an order approving a PMA or declaring 
completed a PDP for the device before the device is commercially 
distributed unless it is reclassified. If FDA knows that a device being 
commercially distributed may be a ``new'' device as defined in this 
section because of any new intended use or other reasons, FDA may codify 
the statutory classification of the device into class III for such new 
use. Accordingly, the regulation for such a class III device states that 
as of the enactment date of the amendments, May 28, 1976, the device 
must have an approval under section 515 of the act before commercial 
distribution.
    (c) A device identified in a regulation in this part that is 
classified into class III and that is subject to the transitional 
provisions of section 520(1) of the act is automatically classified by 
statute into class III and must have an approval under section 515 of 
the act before being commercially distributed. Accordingly, the 
regulation for such a class III transitional device states that as of 
the enactment date of the amendments, May 28, 1976, the device must have 
an approval under section 515 of the act before commercial distribution.

Sec. 886.9  Limitations of exemptions from section 510(k) of the act.

    FDA's decision to grant an exemption from the requirement of 
premarket notification (section 510(k) of the act) for a generic type of 
class I device is based upon the existing and reasonably foreseeable 
characteristics of commercially distributed devices within that generic 
type. Because FDA cannot anticipate every change in intended use or 
characteristic that could significantly affect a device's safety or 
effectiveness, manufacturers of any commercially distributed class I 
device for which FDA has granted an exemption from the requirement of 
premarket notification must still submit a premarket notification to FDA 
before introducing or delivering for introduction into interstate 
commerce for commercial distribution the device when:
    (a) The device is intended for a use different from its intended use 
before May 28, 1976, or the device is intended for a use different from 
the intended use of a preamendments device to which it had been 
determined to be substantially equivalent; e.g., the device is intended 
for a different medical purpose, or the device is intended for lay use 
where the former intended use was by health care professionals only; or
    (b) The modified device operates using a different fundamental 
scientific technology than that in use in the device before May 28, 
1976; e.g., a surgical instrument cuts tissue with a laser beam rather 
than with a sharpened metal blade, or an in vitro diagnostic device 
detects or identifies infectious agents by using a deoxyribonucleic acid 
(DNA) probe or nucleic acid hybridization technology rather than culture 
or immunoassay technology.
[53 FR 35603, Sept. 14, 1988]

[[Page 410]]

                      Subpart B--Diagnostic Devices

Sec. 886.1040  Ocular esthesiometer.

    (a) Identification. An ocular esthesiometer is a device, such as a 
single-hair brush, intended to touch the cornea to assess corneal 
sensitivity.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
59 FR 63012, Dec. 7, 1994]

Sec. 886.1050  Adaptometer (biophotometer).

    (a) Identification. An adaptometer (biophotometer) is an AC-powered 
device that provides a stimulating light source which has various 
controlled intensities intended to measure the time required for retinal 
adaptation (regeneration of the visual purple) and the minimum light 
threshold.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1070  Anomaloscope.

    (a) Identification. An anomaloscope is an AC-powered device intended 
to test for anomalies of color vision by displaying mixed spectral lines 
to be matched by the patient.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1090  Haidlinger brush.

    (a) Identification. A Haidlinger brush is an AC-powered device that 
provides two conical brushlike images with apexes touching which are 
viewed by the patient through a Nicol prism and intended to evaluate 
visual function. It may include a component for measuring macular 
integrity.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1120  Opthalmic camera.

    (a) Identification. An ophthalmic camera is an AC-powered device 
intended to take photographs of the eye and the surrounding area.
    (b) Classification. Class II.
[55 FR 48441, Nov. 20, 1990]

Sec. 886.1140  Ophthalmic chair.

    (a) Identification. An ophthalmic chair is an AC-powered or manual 
device with adjustable positioning in which a patient is to sit or 
recline during ophthalmological examination or treatment.
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1150  Visual acuity chart.

    (a) Identification. A visual acuity chart is a device that is a 
chart, such as a Snellen chart with block letters or other symbols in 
graduated sizes, intended to test visual acuity.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 
53 FR 40825, Oct. 18, 1988]

[[Page 411]]

Sec. 886.1160  Color vision plate illuminator.

    (a) Identification. A color vision plate illuminator is an AC-
powered device that is a lamp intended to properly illuminate color 
vision testing plates. It may include a filter.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1170  Color vision tester.

    (a) Identification. A color vision tester is a device that consists 
of various colored materials, such as colored yarns or color vision 
plates (multicolored plates which patients with color vision deficiency 
would perceive as being of one color), intended to evaluate color 
vision.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988]

Sec. 886.1190  Distometer.

    (a) Identification. A distometer is a device intended to measure the 
distance between the cornea and a corrective lens during refraction to 
help measure the change of the visual image when a lens is in place.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988]

Sec. 886.1200  Optokinetic drum.

    (a) Identification. An optokinetic drum is a drum-like device 
covered with alternating white and dark stripes or pictures that can be 
rotated on its handle. The device is intended to elicit and evaluate 
nystagmus (involuntary rapid movement of the eyeball) in patients.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1220  Corneal electrode.

    (a) Identification. A corneal electrode is an AC-powered device, 
usually part of a special contact lens, intended to be applied directly 
to the cornea to provide data showing the changes in electrical 
potential in the retina after electroretinography (stimulation by 
light).
    (b) Classification. Class II.

Sec. 886.1250  Euthyscope.

    (a) Identification. A euthyscope is a device that is a modified AC-
powered or battery-powered ophthalmoscope (a perforated mirror device 
intended to inspect the interior of the eye) that projects a bright 
light encompassing an arc of about 30 degrees onto the fundus of the 
eye. The center of the light bundle is blocked by a black disk covering 
the fovea (the central depression of the macular retinae where only 
cones are present and blood vessels are lacking). The device is intended 
for use in the treatment of amblyopia (dimness of vision without 
apparent disease of the eye).
    (b) Classification. Class I for the battery powered device. The 
battery powered device is exempt from premarket notification procedures 
in subpart E of part 807 of this chapter. Class II for the AC-powered 
device.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

[[Page 412]]

Sec. 886.1270  Exophthalmometer.

    (a) Identification. An exophthalmometer is a device, such as a 
ruler, gauge, or caliper, intended to measure the degree of exophthalmos 
(abnormal protrusion of the eyeball).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1290  Fixation device.

    (a) Identification. A fixation device is an AC-powered device 
intended for use as a fixation target for the patient during 
ophthalmological examination. The patient directs his or her gaze so 
that the visual image of the object falls on the fovea centralis (the 
center of the macular retina of the eye.)
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1300  Afterimage flasher.

    (a) Identification. An afterimage flasher is an AC-powered light 
that automatically switches on and off to allow performance of an 
afterimage test in which the patient indicates the positions of 
afterimages after the light is off. The device is intended to determine 
harmonious/anomalous retinal correspondence (the condition in which 
corresponding points on the retina have the same directional value).
    (b) Classification. Class II.
[55 FR 48441, Nov. 20, 1990]

Sec. 886.1320  Fornixscope.

    (a) Identification. A fornixscope is a device intended to pull back 
and hold open the eyelid to aid examination of the conjunctiva.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1330  Amsler grid.

    (a) Identification. An Amsler grid is a device that is a series of 
charts with grids of different sizes that are held at 30 centimeters 
distance from the patient and intended to rapidly detect central and 
paracentral irregularities in the visual field.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1340  Haploscope.

    (a) Identification. A haploscope is an AC-powered device that 
consists of two movable viewing tubes, each containing a slide carrier, 
a low-intensity light source for the illumination of the slides, and a 
high-intensity light source for creating afterimages. The device is 
intended to measure strabismus (eye muscle imbalance), to assess 
binocular vision (use of both eyes to see), and to treat suppression and 
amblyopia (dimness of vision without any apparent disease of the eye).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1350  Keratoscope.

    (a) Identification. A keratoscope is an AC-powered or battery-
powered device intended to measure and evaluate the corneal curvature of 
the eye. Lines and circles within the keratoscope are used to observe 
the corneal reflex. This generic type of device includes the 
photokeratoscope which records corneal curvature by taking photographs 
of the cornea.

[[Page 413]]

    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter only when the device does not include computer software in the 
unit. The battery-powered device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
battery-powered device is also exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

Sec. 886.1360  Visual field laser instrument.

    (a) Identification. A visual field laser instrument is an AC-powered 
device intended to provide visible laser radiation that produces an 
interference pattern on the retina to evaluate retinal function.
    (b) Classification. Class II.

Sec. 886.1375  Bagolini lens.

    (a) Identification. A Bagolini lens is a device that consists of a 
plane lens containing almost imperceptible striations that do not 
obscure visualization of objects. The device is placed in a trial frame 
and intended to determine harmonious/anomalous retinal correspondence (a 
condition in which corresponding points on the retina have the same 
directional values).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1380  Diagnostic condensing lens.

    (a) Identification. A diagnostic condensing lens is a device used in 
binocular indirect ophthalmoscopy (a procedure that produces an inverted 
or reversed direct magnified image of the eye) intended to focus 
reflected light from the fundus of the eye.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1385  Polymethylmethacrylate (PMMA) diagnostic contact lens.

    (a) Identification. A polymethylmethacrylate (PMMA) diagnostic 
contact lens is a device that is a curved shell of PMMA intended to be 
applied for a short period of time directly on the globe or cornea of 
the eye for diagnosis or therapy of intraocular abnormalities.
    (b) Classification. Class II.

Sec. 886.1390  Flexible diagnostic Fresnel lens.

    (a) Identification. A flexible diagnostic Fresnel lens is a device 
that is a very thin lens which has its surface a concentric series of 
increasingly refractive zones. The device is intended to be applied to 
the back of the spectacle lenses of patients with aphakia (absence of 
the lens of the eye).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1395  Diagnostic Hruby fundus lens.

    (a) Identification. A diagnostic Hruby fundus lens is a device that 
is a 55 diopter lens intended for use in the examination of the vitreous 
body and the

[[Page 414]]

fundus of the eye under slitlamp illumination and magnification.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1400  Maddox lens.

    (a) Identification. A Maddox lens is a device that is a series of 
red cylinders that change the size, shape, and color of an image. The 
device is intended to be handheld or placed in a trial frame to evaluate 
eye muscle dysfunction.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1405  Ophthalmic trial lens set.

    (a) Identification. An ophthalmic trial lens set is a device that is 
a set of lenses of various dioptric powers intended to be handheld or 
inserted in a trial frame for vision testing to determine refraction.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]

Sec. 886.1410  Ophthalmic trial lens clip.

    (a) Identification. An ophthalmic trial lens clip is a device 
intended to hold prisms, spheres, cylinders, or occluders on a trial 
frame or spectacles for vision testing.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1415  Ophthalmic trial lens frame.

    (a) Identification. An opthalmic trial lens frame is a mechanical 
device intended to hold trial lenses for vision testing.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1420  Ophthalmic lens gauge.

    (a) Identification. An ophthalmic lens gauge is a calibrated device 
intended to manually measure the curvature of a spectacle lens.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]

Sec. 886.1425  Lens measuring instrument.

    (a) Identification. A lens measuring instrument is an AC-powered 
device intended to measure the power of lenses, prisms, and their 
centers (e.g., lensometer).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1430  Ophthalmic contact lens radius measuring device.

    (a) Identification. An ophthalmic contact lens radius measuring 
device is an AC-powered device that is a microscope

[[Page 415]]

and dial gauge intended to measure the radius of a contact lens.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1435  Maxwell spot.

    (a) Identification. A Maxwell spot is an AC-powered device that is a 
light source with a red and blue filter intended to test macular 
function.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1450  Corneal radius measuring device.

    (a) Identification. A corneal radius measuring device is an AC-
powered device intended to measure corneal size by superimposing the 
image of the cornea on a scale at the focal length of the lens of a 
small, hand held, single tube penscope or eye gauge magnifier.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter only 
when the device does not include computer software in the unit or 
topographers.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1460  Stereopsis measuring instrument.

    (a) Identification. A stereopsis measuring instrument is a device 
intended to measure depth perception by illumination of objects placed 
on different planes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1500  Headband mirror.

    (a) Identification. A headband mirror is a device intended to be 
strapped to the head of the user to reflect light for use in examination 
of the eye.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1510  Eye movement monitor.

    (a) Identification. An eye movement monitor is an AC-powered device 
with an electrode intended to measure and record ocular movements.
    (b) Classification. Class II.

Sec. 886.1570  Ophthalmoscope.

    (a) Identification. An ophthalmoscope is an AC-powered or battery-
powered device containing illumination and viewing optics intended to 
examine the media (cornea, aqueous, lens, and vitreous) and the retina 
of the eye.
    (b) Classification. Class II.

Sec. 886.1605  Perimeter.

    (a) Identification. A perimeter is an AC-powered or manual device 
intended to determine the extent of the peripheral visual field of a 
patient. The device projects light on various points of a curved 
surface, and the patient indicates whether he or she sees the light.
    (b) Classification. Class I. The manual device is exempt from the 
premarket notification procedures in part 807, subpart E of this 
chapter, and it is also exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198 with respect to the complaint files.
[55 FR 48442, Nov. 20, 1990]

[[Page 416]]

Sec. 886.1630  AC-powered photostimulator.

    (a) Identification. An AC-powered photostimulator is an AC-powered 
device intended to provide light stimulus which allows measurement of 
retinal or visual function by perceptual or electrical methods (e.g., 
stroboscope).
    (b) Classification. Class II.

Sec. 886.1640  Ophthalmic preamplifier.

    (a) Identification. An ophthalmic preamplifier is an AC-powered or 
battery-powered device intended to amplify electrical signals from the 
eye in electroretinography (recording retinal action currents from the 
surface of the eyeball after stimulation by light), electrooculography 
(testing for retinal dysfunction by comparing the standing potential in 
the front and the back of the eyeball), and electromyography (recording 
electrical currents generated in active muscle).
    (b) Classification. Class II.

Sec. 886.1650  Ophthalmic bar prism.

    (a) Identification. An ophthalmic bar prism is a device that is a 
bar composed of fused prisms of gradually increasing strengths intended 
to measure latent and manifest strabismus (eye muscle deviation) or the 
power of fusion of a patient's eyes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1655  Ophthalmic Fresnel prism.

    (a) Identification. An ophthalmic Fresnel prism is a device that is 
a thin plastic sheet with embossed rulings which provides the optical 
effect of a prism. The device is intended to be applied to spectacle 
lenses to give a prismatic effect.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1660  Gonioscopic prism.

    (a) Identification. A gonioscopic prism is a device that is a prism 
intended to be placed on the eye to study the anterior chamber. The 
device may have angled mirrors to facilitate visualization of anatomical 
features.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]

Sec. 886.1665  Ophthalmic rotary prism.

    (a) Identification. An ophthalmic rotary prism is a device with 
various prismatic powers intended to be handheld and used to measure 
ocular deviation in patients with latent or manifest strabismus (eye 
muscle deviation).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1670  Ophthalmic isotope uptake probe.

    (a) Identification. An ophthalmic isotope uptake probe is an AC-
powered device intended to measure, by a probe which is placed in close 
proximity to the eye, the uptake of a radioisotope (phosphorus 32) by 
tumors to detect

[[Page 417]]

tumor masses on, around, or within the eye.
    (b) Classification. Class II.

Sec. 886.1680  Ophthalmic projector.

    (a) Identification. An ophthalmic projector is an AC-powered device 
intended to project an image on a screen for vision testing.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1690  Pupillograph.

    (a) Identification. A pupillograph is an AC-powered device intended 
to measure the pupil of the eye by reflected light and record the 
responses of the pupil.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1700  Pupillometer.

    (a) Identification. A pupillometer is an AC-powered or manual device 
intended to measure by reflected light the width or diameter of the 
pupil of the eye.
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1750  Skiascopic rack.

    (a) Identification. A skiascopic rack is a device that is a rack and 
a set of attached ophthalmic lenses of various dioptric strengths 
intended as an aid in refraction.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]

Sec. 886.1760  Ophthalmic refractometer.

    (a) Identification. An ophthalmic refractometer is an automatic AC-
powered device that consists of a fixation system, a measurement and 
recording system, and an alignment system intended to measure the 
refractive power of the eye by measuring light reflexes from the retina.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]

Sec. 886.1770  Manual refractor.

    (a) Identification. A manual refractor is a device that is a set of 
lenses of varous dioptric powers intended to measure the refractive 
error of the eye.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1780  Retinoscope.

    (a) Identification. A retinoscope is an AC-powered or battery-
powered device intended to measure the refraction of the eye by 
illuminating the retina and noting the direction of movement of the 
light on the retinal surface and of the refraction by the eye of the 
emergent rays.
    (b) Classification. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered device is exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning

[[Page 418]]

records, and Sec. 820.198, with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]

Sec. 886.1790  Nearpoint ruler.

    (a) Identification. A nearpoint ruler is a device calibrated in 
centimeters intended to measure the nearpoint of convergence (the point 
to which the visual lines are directed when convergence is at its 
maximum).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
53 FR 40825, Oct. 18, 1988]

Sec. 886.1800  Schirmer strip.

    (a) Identification. A Schirmer strip is a device made of filter 
paper or similar material intended to be inserted under a patient's 
lower eyelid to stimulate and evaluate formation of tears.
    (b) Classification. Class I. If the device is made of the same 
materials that were used in the device before May 28, 1976, the device 
is exempt from the premarket notification procedures in part 807, 
subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1810  Tangent screen (campimeter).

    (a) Identification. A tangent screen (campimeter) is an AC-powered 
or battery-powered device that is a large square cloth chart with a 
central mark of fixation intended to map on a flat surface the central 
30 degrees of a patient's visual field. This generic type of device 
includes projection tangent screens, target tangent screens and targets, 
felt tangent screens, and stereo campimeters.
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1840  Simulatan (including crossed cylinder).

    (a) Identification. A simulatan (including crossed cylinder) is a 
device that is a set of pairs of cylinder lenses that provides various 
equal plus and minus refractive strengths. The lenses are arranged so 
that the user can exchange the positions of plus and minus cylinder 
lenses of equal strengths. The device is intended for subjective 
refraction (refraction in which the patient judges whether a given 
object is clearly in focus, as the examiner uses different lenses).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]

Sec. 886.1850  AC-powered slitlamp biomicroscope.

    (a) Identification. An AC-powered slitlamp biomicroscope is an AC-
powered device that is a microscope intended for use in eye examination 
that projects into a patient's eye through a control diaphragm a thin, 
intense beam of light.
    (b) Classification. Class II.

Sec. 886.1860  Ophthalmic instrument stand.

    (a) Identification. An ophthalmic instrument stand is an AC-powered 
or nonpowered device intended to store ophthalmic instruments in a 
readily accessible position.

[[Page 419]]

    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1870  Stereoscope.

    (a) Identification. A stereoscope is an AC-powered or battery-
powered device that combines the images of two similar objects to 
produce a three-dimensional appearance of solidity and relief. It is 
intended to measure the angle of strabismus (eye muscle deviation), 
evaluate binocular vision (usage of both eyes to see), and guide a 
patient's corrective exercises of eye muscles.
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.1880  Fusion and stereoscopic target.

    (a) Identification. A fusion and stereoscopic target is a device 
intended for use as a viewing object with a stereoscope (Sec. 886.1870).
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]

Sec. 886.1905  Nystagmus tape.

    (a) Identification. Nystagmus tape is a device that is a long, 
narrow strip of fabric or other flexible material on which a series of 
objects are printed. The device is intended to be moved across a 
patient's field of vision to elicit optokinetic nystagmus (abnormal and 
irregular eye movements) and to test for blindness.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]

Sec. 886.1910  Spectacle dissociation test system.

    (a) Identification. A spectacle dissociation test system is an AC-
powered or battery-powered device, such as a Lancaster test system, that 
consists of a light source and various filters, usually red or green 
filters, intended to subjectively measure imbalance of ocular muscles.
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 
59 FR 63013, Dec. 7, 1994]

Sec. 886.1930  Tonometer and accessories.

    (a) Identification. A tonometer and accessories is a manual device 
intended

[[Page 420]]

to measure intraocular pressure by applying a known force on the globe 
of the eye and measuring the amount of indentation produced (Schiotz 
type) or to measure intraocular tension by applanation (applying a small 
flat disk to the cornea). Accessories for the device may include a 
tonometer calibrator or a tonograph recording system. The device is 
intended for use in the diagnosis of glaucoma.
    (b) Classification. Class II.

Sec. 886.1940  Tonometer sterilizer.

    (a) Identification. A tonometer sterilizer is an AC-powered device 
intended to heat sterilize a tonometer (a device used to measure 
intraocular pressure).
    (b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]

Sec. 886.1945  Transilluminator.

    (a) Identification. A transilluminator is an AC-powered or battery-
powered device that is a light source intended to transmit light through 
tissues to aid examination of patients.
    (b) Classification. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered Class I device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

                          Subpart C  [Reserved]

                      Subpart D--Prosthetic Devices

Sec. 886.3100  Ophthalmic tantalum clip.

    (a) Identification. An ophthalmic tantalum clip is a malleable 
metallic device intended to be implanted permanently or temporarily to 
bring together the edges of a wound to aid healing or prevent bleeding 
from small blood vessels in the eye.
    (b) Classification. Class II.

Sec. 886.3130  Ophthalmic conformer.

    (a) Identification. An ophthalmic conformer is a device usually made 
of molded plastic intended to be inserted temporarily between the 
eyeball and eyelid to maintain space in the orbital cavity and prevent 
closure or adhesions during the healing process following surgery.
    (b) Classification. Class II.

Sec. 886.3200  Artificial eye.

    (a) Identification. An artificial eye is a device resembling the 
anterior portion of the eye, usually made of glass or plastic, intended 
to be inserted in a patient's eye socket anterior to an orbital implant, 
or the eviscerated eyeball, for cosmetic purposes. The device is not 
intended to be implanted.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter if the 
device is made from the same materials, has the same chemical 
composition, and uses the same manufacturing processes as currently 
legally marketed devices.
[61 FR 1124, Jan. 16, 1996]

Sec. 886.3300  Absorbable implant (scleral buckling method).

    (a) Identification. An absorbable implant (scleral buckling method) 
is a device intended to be implanted on the sclera to aid retinal 
reattachment.
    (b) Classification. Class II.

Sec. 886.3320  Eye sphere implant.

    (a) Identification. An eye sphere implant is a device intended to be 
implanted in the eyeball to occupy space following the removal of the 
contents of the eyeball with the sclera left intact.
    (b) Classification. Class II.

Sec. 886.3340  Extraocular orbital implant.

    (a) Identification. An extraocular orbital implant is a 
nonabsorbable device intended to be implanted during scleral surgery for 
buckling or building up the floor of the eye, usually in conjunction 
with retinal reattachment. Injectable substances are excluded.
    (b) Classification. Class II.

Sec. 886.3400  Keratoprosthesis.

    (a) Identification. A keratoprosthesis is a device made of plastic 
intended to be implanted to replace the central area of an opacified 
natural cornea of the eye to maintain or restore sight.
    (b) Classification. Class III.

[[Page 421]]

    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 886.3.

Sec. 886.3600  Intraocular lens.

    (a) Identification. An intraocular lens is a device made of 
materials such as glass or plastic intended to be implanted to replace 
the natural lens of an eye.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.

Sec. 886.3800  Scleral shell.

    (a) Identification. A scleral shell is a device made of glass or 
plastic that is intended to be inserted for short time periods over the 
cornea and proximal-cornea sclera for cosmetic or reconstructive 
purposes. An artificial eye is usually painted on the device. The device 
is not intended to be implanted.
    (b) Classification. Class II.

Sec. 886.3920  Eye valve implant.

    (a) Identification. An eye valve implant is a one-way, pressure-
sensitive, valve-like device intended to be implanted to normalize 
intraocular pressure. The device may be used in the treatment of 
glaucoma.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. No 
effective date has been established of the requirement for premarket 
approval. See Sec. 886.3.

                       Subpart E--Surgical Devices

Sec. 886.4070  Powered corneal burr.

    (a) Identification. A powered corneal burr is an AC-powered or 
battery-powered device that is a motor and drilling tool intended to 
remove rust rings from the cornea of the eye.
    (b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]

Sec. 886.4100  Radiofrequency electrosurgical cautery apparatus.

    (a) Identification. A radiofrequency electrosurgical cautery 
apparatus is an AC-powered or battery-powered device intended for use 
during ocular surgery to coagulate tissue or arrest bleeding by a high 
frequency electric current.
    (b) Classification. Class II.

Sec. 886.4115  Thermal cautery unit.

    (a) Identification. A thermal cautery unit is an AC-powered or 
battery-powered device intended for use during ocular surgery to 
coagulate tissue or arrest bleeding by heat conducted through a wire 
tip.
    (b) Classification. Class II.

Sec. 886.4150  Vitreous aspiration and cutting instrument.

    (a) Identification. A vitreous aspiration and cutting instrument is 
an electrically powered device, which may use ultrasound, intended to 
remove vitreous matter from the vitreous cavity or remove a crystalline 
lens.
    (b) Classification. Class II.

Sec. 886.4170  Cryophthalmic unit.

    (a) Identification. A cryophthalmic unit is a device that is a probe 
with a small tip that becomes extremely cold through the controlled use 
of a refrigerant or gas. The device may be AC-powered. The device is 
intended to remove cataracts by the formation of an adherent ice ball in 
the lens, to freeze the eye and adjunct parts for surgical removal of 
scars, and to freeze tumors.
    (b) Classification. Class II.

Sec. 886.4230  Ophthalmic knife test drum.

    (a) Identification. An ophthalmic knife test drum is a device 
intended to test the keenness of ophthalmic surgical knives to determine 
whether resharpening is needed.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]

[[Page 422]]

Sec. 886.4250  Ophthalmic electrolysis unit.

    (a) Identification. An ophthalmic electrolysis unit is an AC-powered 
or battery-powered device intended to destroy ocular hair follicles by 
applying a galvanic electrical current.
    (b) Classification. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery-powered Class I device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]

Sec. 886.4270  Intraocular gas.

    (a) Identification. An intraocular gas is a device consisting of a 
gaseous fluid intended to be introduced into the eye to place pressure 
on a detached retina.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.

Sec. 886.4275  Intraocular fluid.

    (a) Identification. An intraocular fluid is a device consisting of a 
nongaseous fluid intended to be introduced into the eye to aid 
performance of surgery, such as to maintain anterior chamber depth, 
preserve tissue integrity, protect tissue from surgical trauma, or 
function as a tamponade during retinal reattachment.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.

Sec. 886.4280  Intraocular pressure measuring device.

    (a) Identification. An intraocular pressure measuring device is a 
manual or AC-powered device intended to measure intraocular pressure. 
Also included are any devices found by FDA to be substantially 
equivalent to such devices. Accessories for the device may include 
calibrators or recorders. The device is intended for use in the 
diagnosis of glaucoma.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before 
this device may be commercially distributed. See Sec. 886.3.

Sec. 886.4300  Intraocular lens guide.

    (a) Identification. An intraocular lens guide is a device intended 
to be inserted into the eye during surgery to direct the insertion of an 
intraocular lens and be removed after insertion is completed.
    (b) Classification. Class I.

Sec. 886.4335  Operating headlamp.

    (a) Identification. An operating headlamp is an AC-powered or 
battery-powered device intended to be worn on the user's head to provide 
a light source to aid visualization during surgical, diagnostic, or 
therapeutic procedures.
    (b) Classification. Class I for the battery-powered device. Class II 
for the AC-powered device. The battery powered-device is exempt from the 
premarket notification procedures in part 807, subpart E of this 
chapter.
[55 FR 48443, Nov. 20, 1990]

Sec. 886.4350  Manual ophthalmic surgical instrument.

    (a) Identification. A manual ophthalmic surgical instrument is a 
nonpowered, handheld device intended to aid or perform ophthalmic 
surgical procedures. This generic type of device includes the manual 
corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, 
ophthalmic muscle clamp, iris retractor clip, orbital compressor, 
ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, 
erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere 
introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal 
probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, 
ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, 
enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic 
spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

[[Page 423]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995]

Sec. 886.4360  Ocular surgery irrigation device.

    (a) Identification. An ocular surgery irrigation device is a device 
intended to be suspended over the ocular area during ophthalmic surgery 
to deliver continuous, controlled irrigation to the surgical field.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]

Sec. 886.4370  Keratome.

    (a) Identification. A keratome is an AC-powered or battery-powered 
device intended to shave tissue from sections of the cornea for a 
lamellar (partial thickness) transplant.
    (b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]

Sec. 886.4390  Ophthalmic laser.

    (a) Identification. An ophthalmic laser is an AC-powered device 
intended to coagulate or cut tissue of the eye, orbit, or surrounding 
skin by a laser beam.
    (b) Classification. Class II.

Sec. 886.4392  Nd:YAG laser for posterior capsulotomy.

    (a) Identification. The Nd:YAG laser for posterior capsulotomy 
consists of a mode-locked or Q-switched solid state Nd:YAG laser 
intended for posterior capsulotomy, which generates short pulse, low 
energy, high power, coherent optical radiation. When the laser output is 
combined with focusing optics, the high irradiance at the target causes 
tissue disruption via optical breakdown. A visible aiming system is 
utilized to target the invisible Nd:YAG laser radiation on or in close 
proximity to the target tissue.
    (b) Classification. Class II.
[53 FR 38947, Oct. 4, 1988]

Sec. 886.4400  Electronic metal locator.

    (a) Identification. An electronic metal locator is an AC-powered 
device with probes intended to locate metallic foreign bodies in the eye 
or eye socket.
    (b) Classification. Class II.

Sec. 886.4440  AC-powered magnet.

    (a) Identification. An AC-powered magnet is an AC-powered device 
that generates a magnetic field intended to find and remove metallic 
foreign bodies from eye tissue.
    (b) Classification. Class II.

Sec. 886.4445  Permanent magnet.

    (a) Identification. A permanent magnet is a nonelectric device that 
generates a magnetic field intended to find and remove metallic foreign 
bodies from eye tissue.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]

Sec. 886.4570  Ophthalmic surgical marker.

    (a) Identification. An ophthalmic surgical marker is a device 
intended to mark by use of ink, dye, or indentation the location of 
ocular or scleral surgical manipulation.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994]

Sec. 886.4610  Ocular pressure applicator.

    (a) Identification. An ocular pressure applicator is a manual device 
that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, 
a band,

[[Page 424]]

and bellows, intended to apply pressure on the eye in preparation for 
ophthalmic surgery.
    (b) Classification. Class II.

Sec. 886.4670  Phacofragmentation system.

    (a) Identification. A phacofragmentation system is an AC-powered 
device with a fragmenting needle intended for use in cataract surgery to 
disrupt a cataract with ultrasound and extract the cataract.
    (b) Classification. Class II.

Sec. 886.4690  Ophthalmic photocoagulator.

    (a) Identification. An ophthalmic photocoagulator is an AC-powered 
device intended to use the energy from an extended noncoherent light 
source to occlude blood vessels of the retina, choroid, or iris.
    (b) Classification. Class II.

Sec. 886.4750  Ophthalmic eye shield.

    (a) Identification. An ophthalmic eye shield is a device that 
consists of a plastic or aluminum eye covering intended to protect the 
eye or retain dressing materials in place.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994]

Sec. 886.4770  Ophthalmic operating spectacles (loupes).

    (a) Identification. Ophthalmic operating spectacles (loupes) are 
devices that consist of convex lenses or lens systems intended to be 
worn by a surgeon to magnify the surgical site during ophthalmic 
surgery.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]

Sec. 886.4790  Ophthalmic sponge.

    (a) Identification. An ophthalmic sponge is a device that is an 
absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose, 
or other material intended to absorb fluids from the operative field in 
ophthalmic surgery.
    (b) Classification. Class II.

Sec. 886.4855  Ophthalmic instrument table.

    (a) Identification. An ophthalmic instrument table is an AC-powered 
or manual device on which ophthalmic instruments are intended to be 
placed.
    (b) Classification. Class I. The AC-powered device and the manual 
device are exempt from the premarket notification procedures in subpart 
E of part 807 of this chapter. The manual device is also exempt from the 
current good manufacturing practice regulations in part 820 of this 
chapter, with the exception of Sec. 820.180, with respect to general 
requirements concerning records, and Sec. 820.198, with respect to 
complaint files.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

                     Subpart F--Therapeutic Devices

Sec. 886.5100  Ophthalmic beta radiation source.

    (a) Identification. An ophthalmic beta radiation source is a device 
intended to apply superficial radiation to benign and malignant ocular 
growths.
    (b) Classification. Class II.

Sec. 886.5120  Low-power binocular loupe.

    (a) Identification. A low-power binocular loupe is a device that 
consists of two eyepieces, each with a lens or lens system, intended for 
medical purposes to magnify the appearance of objects.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E

[[Page 425]]

of this chapter. The device also is exempt from the current good 
manufacturing practice regulations in part 820 of this chapter, with the 
exception of Sec. 820.180, with respect to general requirements 
concerning records, and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5420  Contact lens inserter/remover.

    (a) Identification. A contact lens inserter/remover is a handheld 
device intended to insert or remove contact lenses by surface adhesion 
or suction.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5540  Low-vision magnifier.

    (a) Identification. A low-vision magnifier is a device that consists 
of a magnifying lens intended for use by a patient who has impaired 
vision. The device may be held in the hand or attached to spectacles.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5600  Ptosis crutch.

    (a) Identification. A ptosis crutch is a device intended to be 
mounted on the spectacles of a patient who has ptosis (drooping of the 
upper eyelid as a result of faulty development or paralysis) to hold the 
upper eyelid open.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5800  Ophthalmic bar reader.

    (a) Identification. An ophthalmic bar reader is a device that 
consists of a magnifying lens intended for use by a patient who has 
impaired vision. The device is placed directly onto reading material to 
magnify print.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5810  Ophthalmic prism reader.

    (a) Identification. An ophthalmic prism reader is a device intended 
for use by a patient who is in a supine position to change the angle of 
print to aid reading.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5820  Closed-circuit television reading system.

    (a) Identification. A closed-circuit television reading system is a 
device that consists of a lens, video camera, and video monitor that is 
intended for use by a patient who has subnormal vision to magnify 
reading material.

[[Page 426]]

    (b) Classification. Class I. The AC-powered device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

Sec. 886.5840  Magnifying spectacles.

    (a) Identification. Magnifying spectacles are devices that consist 
of spectacle frames with convex lenses intended to be worn by a patient 
who has impaired vision to enlarge images.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994]

Sec. 886.5842  Spectacle frame.

    (a) Identification. A spectacle frame is a device made of metal or 
plastic intended to hold prescription spectacle lenses worn by a patient 
to correct refractive errors.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994]

Sec. 886.5844  Prescription spectacle lens.

    (a) Identification. A prescription spectacle lens is a glass or 
plastic device that is a lens intended to be worn by a patient in a 
spectacle frame to provide refractive corrections in accordance with a 
prescription for the patient. The device may be modified to protect the 
eyes from bright sunlight (i.e., prescription sunglasses). Prescription 
sunglass lenses may be reflective, tinted, polarizing, or 
photosensitized.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 
59 FR 63014, Dec. 7, 1994]

Sec. 886.5850  Sunglasses (nonprescription).

    (a) Identification. Sunglasses (nonprescription) are devices that 
consist of spectacle frames or clips with absorbing, reflective, tinted, 
polarizing, or photosensitized lenses intended to be worn by a person to 
protect the eyes from bright sunlight but not to provide refractive 
corrections. This device is usually available over-the-counter.
    (b) Classification. Class I.

Sec. 886.5870  Low-vision telescope.

    (a) Identification. A low-vision telescope is a device that consists 
of an arrangement of lenses or mirrors intended for use by a patient who 
has impaired vision to increase the apparent size of objects. This 
generic type of device includes handheld or spectacle telescopes.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5900  Electronic vision aid.

    (a) Identification. An electronic vision aid is an AC-powered or 
battery-powered device that consists of an electronic sensor/transducer 
intended for use by a patient who has impaired vision or blindness to 
translate visual images of objects into tactile or auditory signals.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

Sec. 886.5910  Image intensification vision aid.

    (a) Identification. An image intensification vision aid is a 
battery-powered device intended for use by a patient who has limited 
dark adaptation or impaired vision to amplify ambient light.

[[Page 427]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in part 807, subpart E of this chapter. The 
device also is exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]

Sec. 886.5915  Optical vision aid.

    (a) Identification. An optical vision aid is a device that consists 
of a magnifying lens with an accompanying AC-powered or battery-powered 
light source intended for use by a patient who has impaired vision to 
increase the apparent size of object detail.
    (b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in 
subpart E of part 807 of this chapter. The battery-powered device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]

Sec. 886.5916  Rigid gas permeable contact lens.

    (a) Identification. A rigid gas permeable contact lens is a device 
intended to be worn directly against the cornea of the eye to correct 
vision conditions. The device is made of various materials, such as 
cellulose acetate butyrate, polyacrylate-silicone, or silicone 
elastomers, whose main polymer molecules generally do not absorb or 
attract water.
    (b) Classification. (1) Class II if the device is intended for daily 
wear only.
    (2) Class III if the device is intended for extended wear.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before a 
device described in paragraph (b)(2) of this section may be commercially 
distributed. See Sec. 886.3.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]

Sec. 886.5918  Rigid gas permeable contact lens care products.

    (a) Identification. A rigid gas permeable contact lens care product 
is a device intended for use in the cleaning, conditioning, rinsing, 
lubricating/rewetting, or storing of a rigid gas permeable contact lens. 
This includes all solutions and tablets used together with rigid gas 
permeable contact lenses.
    (b) Classification. Class II (Special Controls) Guidance Document: 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''
[62 FR 30987, June 6, 1997]

Sec. 886.5925  Soft (hydrophilic) contact lens.

    (a) Identification. A soft (hydrophilic) contact lens is a device 
intended to be worn directly against the cornea and adjacent limbal and 
scleral areas of the eye to correct vision conditions or act as a 
therapeutic bandage. The device is made of various polymer materials the 
main polymer molecules of which absorb or attract a certain volume 
(percentage) of water.
    (b) Classification. (1) Class II if the device is intended for daily 
wear only.
    (2) Class III if the device is intended for extended wear.
    (c) Date PMA or notice of completion of a PDP is required. As of May 
28, 1976, an approval under section 515 of the act is required before a 
device described in paragraph (b)(2) of this section may be commercially 
distributed. See Sec. 886.3.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]

Sec. 886.5928  Soft (hydrophilic) contact lens care products.

    (a) Identification. A soft (hydrophilic) contact lens care product 
is a device intended for use in the cleaning, rinsing, disinfecting, 
lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. 
This includes all solutions

[[Page 428]]

and tablets used together with soft (hydrophilic) contact lenses and 
heat disinfecting units intended to disinfect a soft (hydrophilic) 
contact lens by means of heat.
    (b) Classification. Class II (Special Controls) Guidance Document: 
``Guidance for Industry Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products.''
[62 FR 30988, June 6, 1997]

Sec. 886.5933  [Reserved]
 

Back to the Year 2000 page

(Uploaded February 26, 1999)