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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 NumberS023
Date Received11/18/2005
Decision Date05/01/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL TO INCREASE THE PULSE REPETITION RATE OF THE LADAR 6000 EXCIMER LASER FROM 60 HZ TO 92 HX.
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