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: WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
• Generic Name: Excimer laser system
• Applicant: Alcon Laboratories, Inc.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P020050
• Supplement Number: S004
• Date Received: 01/30/2006
• Decision Date: 07/26/2006
• Product Code: LZS
• Docket Number: 06M-0325
• Notice Date: 08/17/2006
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO ANALYZER. THE DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM ABLATION/TREATMENT ZONE, AND IS INDICATED FOR WAVEFRONT-GUIDED (WFG) LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF UP TO -7.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WITH ASTIGMATISM, WITH UP TO -7.00 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; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D 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