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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.
 
DeviceVisumax; VISUMAX 800
Generic NameFemtosecond laser system for refractive correction
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP150040
Supplement NumberS021
Date Received07/25/2025
Decision Date08/21/2025
Product Code OTL 
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  
approval of a new supplier for the slider component of the OPMI arm of the VISUMAX 800 Femtosecond Laser
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