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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.
 
DeviceLADAR VISION EXCIMER LASER SYSTEM (HYPEROPIA)
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS007
Date Received09/03/1999
Decision Date09/22/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1612
Notice Date 11/21/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE LADARVISION(R) EXCIMER LASER SYSTEM. THE DEVICE IS INDICATED FOR LASER IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS: 1) FOR THE REDUCTION OR ELIMINATINO OF REFRACTIVE ERROR OF LESS THAN OR EQUAL TO +6.00D OF SPHERE AND -6.00D OF CYLINDER AT THE SPECTACLE PLANE (HYPEROPIA WITH OR WITHOUT ASTIGMATISM AND MIXED ASTIGMATISM); 1) IN SUBJECTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50D FOR CORRECTIONS UP TO +6.00D SE; AND, 3) IN SUBJECTS WHO ARE 21 YEARS OF AGE OR OLDER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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