|
Device | VISX STAR S2 EXCIMER LASER SYSTEM |
Generic Name | excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 cottonwood drive milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S007 |
Date Received | 03/05/1998 |
Decision Date | 11/02/1998 |
Product Code |
LZS |
Docket Number | 00M-1391 |
Notice Date | 07/14/2000 |
Advisory Committee |
Ophthalmic |
Supplement Type | panel track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the VISX Excimer Laser System. This device is indicated for hyperopic PRK using an ablation zone with a correction diameter of 5.0 mm and an overall diameter of 9.0mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|