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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceWAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS004
Date Received01/30/2006
Decision Date07/26/2006
Product Code LZS 
Docket Number 06M-0325
Notice Date 08/17/2006
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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