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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 NumberS020
Date Received06/23/2025
Decision Date12/18/2025
Product Code OTL 
Advisory Committee Ophthalmic
Clinical TrialsNCT05740293
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
labeling update that includes the Post-Approval study data from the VisuMax SMILE New Enrollment Study for the VisuMax Femtosecond Laser
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