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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
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