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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceWAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP020050
Date Received11/20/2002
Decision Date10/07/2003
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 03M-0491
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 DEVICE USED OPTICAL ZONES OF 6.0 AND 6.5 MM WITH AN ABLATION/TREATMENT ZONE UP TO 9.0 MM, AND S INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA OF UP TO -12.0 DIOPTERS (D) OF SPHERE AND UP TO -6.0 D OF ASTIGMATISM 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 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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
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