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 south freeway; fort worth, TX 76134-2099
• 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

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: S022 S020 S014 S007 S004 S001 S005 S003 ; S002 S009 S015 S019 S016 S010 S018 S013 S011 ; S017 S008 S012 S006 S032 S027 S033 S030 S031 ; S028 S029 S024 S026 S025 S023