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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 SYSTEM
Classification Namefemtosecond laser system for refractive correction
Generic Namefemtosecond laser system for refractive correction
Applicant
Carl Zeiss Meditec, Inc.
5160 hacienda drive
dublin, CA 94568
PMA NumberP150040
Supplement NumberS001
Date Received01/06/2017
Decision Date02/28/2017
Product Code
OTL[ Registered Establishments with OTL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software changes.
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