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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 6000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS019
Date Received11/30/2004
Decision Date05/01/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR CHANGES IN THE LADARVISION 4000 SYSTEM INCLUDING A NEW CONFIGURATION OF THE ILLUMINATION SYSTEM, UPGRADES TO THE LASER COMPUTER AND OPERATING SYSTEM, AND VARIOUS OTHER HARDWARE AND SOFTWARE CHANGES INTENDED TO ADDRESS COMPLIANCE WITH EMI REQUIREMENTS, MANAGE COMPONENT OBSOLESCENCE, REDUCE MAINTENANCE REQUIREMENTS, AND ENHANCE ERGONOMIC AND USER INTERFACE FEATURES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LADAR 6000 EXCIMER LASER SYSTEM.
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