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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 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS005
Date Received09/03/1999
Decision Date05/09/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1593
Notice Date 11/14/2000
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 LADARVision Excimer Laser System indicated for laser in-situ keratomileusis (LASIK).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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