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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 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES,INC
PMA NumberP970043
Supplement NumberS026
Date Received09/28/2006
Decision Date11/01/2006
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a software change to the wavefront-image gathering sequence in the customcornea surgery planning software to allow for different pre-op and surgery days; a change to the ladar6000 software to allow for conventional centration photos to be imported from the ladarwave customcornea wavefront system; and, minor enhancements/bug fixes to the ladarvision 4000 software, the ladar6000 system software, and the customcornea surgery planning software.
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