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 | ALLEGRETTO WAVE EYE-Q 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 | S017 |
Date Received | 02/02/2015 |
Decision Date | 05/01/2015 |
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 TO EXPAND THE APPROVAL OF THE TOPOLYZER VARIO TO INCLUDE ITS USE AS A DIAGNOSTIC DEVICE SUPPORTING THE WAVELIGHT EXCIMER LASERS IN PERFORMING T-CAT LASIK. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRO TOPOLYZER VARIO AND IS INDICATED FOR THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) OR ALLEGRO TOPOLYZER VARIO (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK):1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00 D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE;2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50 D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY. |
|
|