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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLADAR VISION EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP970043
Supplement NumberS006
Date Received09/22/1999
Decision Date01/07/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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