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. |
|
Device | WAVELIGHT ALLEGRETTO WAVE 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 | S012 |
Date Received | 07/22/2013 |
Decision Date | 10/18/2013 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE. |
|
|