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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 Femtosecond Laser
Classification Namefemtosecond laser system for refractive correction
Generic Namefemtosecond laser system for refractive correction
Carl Zeiss Meditec, Inc.
5160 hacienda drive
dublin, CA 94568
PMA NumberP150040
Supplement NumberS004
Date Received12/11/2018
Decision Date07/25/2019
Product Code
OTL[ Registered Establishments with OTL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the protocol for the post-approval study (PAS) protocol.