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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.
 
DeviceLASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
Generic Nameexcimer laser system
Applicant
LASERSIGHT TECHNOLOGIES, INC.
6903 university blvd.,
winter park, FL 32792
PMA NumberP980008
Supplement NumberS005
Date Received12/19/2000
Decision Date09/28/2001
Product Code LZS 
Docket Number 01M-0490
Notice Date 10/26/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE LASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK). THE DEVICE IS INDICATED FOR LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM -0.5 TO LESS THAN -6.0 DIOPTERS (D) SPHERICAL EQUIVALENT, WITH ASTIGMATISM LESS THAN OR EQUAL TO 4.5 D, AS MEASURED AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS <= 0.50 D, OR <= 10% OF PREOPERATIVE SPHERICAL EQUIVALENT REFRACTION (SER) SHIFT OVER ONE YEAR PRIOR TO SURGERY; AND, 3) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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