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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 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP020050
Supplement NumberS010
Date Received11/05/2012
Decision Date11/25/2013
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.
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