Premarket Approval (PMA) Database
| Trade Name | VIEWPOINT(TM) CK SYSTEM |
|---|
| Classification Name |
electrosurgical,radio frequency,refractive correction
|
| Generic Name | rf electrosurgical device |
| Applicant |
REFRACTEC, INC.
|
| PMA Number | P010018 |
| Date Received | 03/14/2001 |
| Decision Date | 04/11/2002 |
| Product Code | MWD |
| Docket Number | 02M-0174 |
| Date Notice | 04/25/2002 |
| Advisory Committee |
Ophthalmic
|
| Expedited Review Granted? |
No
| | Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
| Approval Order Statement
Approval for the refractec viewpoint ck system.
This device is indicated for: temporary reduction of spherical hyperopia in patients who have 0.
75 d to 3.
25 d of cycloplegic spherical hyperopia, less than or equal to 0.
75 d of refractive astigmatism (minus cylinder format), a cycloplegic spherical equivalent of 0.
75 d to 3.
00 d, and are 40 years of age or greater with a documented stability of refraction for the prior 12 month, as demonstrated by a change of less than 0.
50 d in spherical and cylindrical components of the manifest refraction.
The magnitude of correction with this treatment diminishes over time, with some patients retaining some or all of their intended refractive correction.
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