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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.
 
DeviceLADARVISION 4000 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP970043
Supplement NumberS010
Date Received03/18/2002
Decision Date10/18/2002
Withdrawal Date 05/15/2012
Product Code LZS 
Docket Number 02M-0487
Notice Date 11/18/2002
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THIS DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -7.0 DIOPTERS (D) AS MEASURED BY MANIFEST REFRACTION, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50 D.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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