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
• Classification Name: 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 [ Registered Establishments with 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: S001 S002 S003 S004 S005 S006 S007 S008 S009 ; S010 S011 S012 S013 S014 S015 S016 S017 S018 ; S019 S020 S022