Premarket Approval (PMA)

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: P020050
• Supplement Number: S012
• Date Received: 04/01/2013
• Decision Date: 09/27/2013
• Product Code: LZS
• Docket Number: 13M-1321
• Notice Date: 10/30/2013
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT01028378
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE ALLEGRETTO WAVE® EYE-Q 400HZ EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING: THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (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 -3.00D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.¿

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2