Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• 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: P030008
• Date Received: 03/19/2003
• Decision Date: 10/10/2003
• Product Code: LZS
• Docket Number: 03M-0492
• Notice Date: 10/28/2003
• Advisory Committee: Ophthalmic
• 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. THE DEVICES USES OPTICAL ZONES OF 6.0 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 DIOPTERS (D) OF SPHERE WITH AND WITHOUT ASTIGMATIC REFRACTIVE ERRORS UP TO 5.0 D AT THE SPECTACLE PLANE, WITH A MAXIMUM MANIFEST REFRACTION SPHERICAL EQUIVALENT (MRSE) OF +6.0 D; 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, EXCLUSIVE OF CHANGES DUE TO UNMASKING LATENT HYPEROPIA.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Supplements: S006 S005 S008 S011 S015 S017 S002 S001 S004 S022 S007 ; S013 S014 S010 S018 S019 S009 S016 S020 S012 S003 S025 S026 ; S036 S039 S023 S024 S029 S032 S030 S031 S028 S027 S034 S033 ; S035 S038 S037