| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
| |
| Trade Name | NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK) |
|---|
| Classification Name | excimer laser system |
|---|
| Applicant | NIDEK TECHNOLOGIES, INC. |
|---|
| PMA Number | P970053 |
|---|
| Supplement Number | S001 |
|---|
| Date Received | 02/16/1999 |
|---|
| Decision Date | 09/29/1999 |
|---|
| Product Code | |
| Docket Number | 00M-1664 |
|---|
| Notice Date | 12/13/2000 |
|---|
| Advisory Committee |
Ophthalmic |
|---|
| Supplement Type | panel track |
|---|
| Supplement Reason | labeling change - indications |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the nidek ec-5000 excimer laser system for photorefractive keratectomy for moderate myopia with astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1. 00 to -8. 00 diopters (d), in terms of manifest refraction spherical equivalent (mrse), with refractive astigmatism ranging in severity from -0. 5 to -4. 00 d cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i. E. , magnitude of change in manifest refraction of <0. 5d per year in terms of mrse for at least one year proceeding treatment) and pretreatment astigmatism (i. E. , a magnitude of change of <0. 5d per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age. |
| Approval Order |
Approval Order
|
|
|
