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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.
 
DeviceMEL 90 Excimer Laser
Generic NameExcimer laser system
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP060004
Supplement NumberS011
Date Received04/06/2026
Decision Date04/30/2026
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
updates to the quality inspection process for the Fluence Test Cards
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