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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 South Freeway
Fort Worth, TX 76134-2099
PMA NumberP030008
Supplement NumberS035
Date Received09/02/2021
Decision Date11/19/2021
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 a hardware design change to the WaveLight EX500 Laser.
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