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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.
 
DeviceWAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP020050
Supplement NumberS014
Date Received07/22/2013
Decision Date10/18/2013
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.
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