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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
Generic NameExcimer laser system
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP970043
Supplement NumberS023
Date Received11/18/2005
Decision Date05/01/2006
Withdrawal Date05/15/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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