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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.
 
DeviceLADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE
Generic NameExcimer laser system
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP970043
Supplement NumberS026
Date Received09/28/2006
Decision Date11/01/2006
Withdrawal Date05/15/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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