Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | P030008 |
Supplement Number | S009 |
Date Received | 11/05/2012 |
Decision Date | 11/25/2013 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES. |
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