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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.
 
DeviceLADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
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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