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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 EX500 LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP020050
Supplement NumberS021
Date Received02/27/2015
Decision Date06/02/2015
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028) THE DEVICES, AS MODIFIED, WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAMES WAVELIGHT® EX500 EXCIMER LASER SYSTEM - EXCIMER LASER SYSTEM (MODEL 1016-3), WAVENET PLANNING SOFTWARE (WPS) - STANDALONE SOFTWARE. (MODEL 6164), AND ALLEGRO TOPOLYZER VARIO - TOPOGRAPHER (MODEL 1028).
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