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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceALLEGRETTO WAVE EYE-Q LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon 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[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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