|
Device | WAVELIGHT EX500 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P020050 |
Supplement Number | S013 |
Date Received | 04/17/2013 |
Decision Date | 05/15/2013 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LABELING CHANGES OF WAVELIGHT® EX 500 EXCIMER LASER SYSTEM AND WAVELIGHT LASER SYSTEM. |