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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 NameLADARVISION EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON UNIVERSAL, LTD.
PMA NumberP970043
Supplement NumberS009
Date Received08/04/2000
Decision Date08/28/2000
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 
Approval for reducing by 20% the ablation depth values that are provided in the physician booklet and displayed by the device.
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