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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
Generic NameExcimer laser system
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP970043
Supplement NumberS006
Date Received09/22/1999
Decision Date01/07/2000
Withdrawal Date05/15/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of the following statement to the warnings section: "A minimum of pre-operative pupillary dilation of 7mm and a maximum dilation of 11mm must be achieved and maintained in all patients throughout the refractive procedure to optimize tracker performance.
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