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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.
 
DeviceALLEGRETTO WAVE EYE-Q LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS003
Date Received04/01/2005
Decision Date06/16/2006
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN REPETITION RATE FROM 200 HZ TO 400 HZ. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM AND IS INDICATED FOR LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER: 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 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; AND 2) FOR THE REDUCTION OR ELIMINATION OF HYPEROPIC REFRACTIVE ERRORS UP TO +6.0 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 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.
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