VisuMax Femtosecond Laser

FDA Premarket Approval P150040 S010

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.

Pre-market Approval Supplement Details

DeviceVisuMax Femtosecond Laser
Generic NameFemtosecond Laser System For Refractive Correction
ApplicantCarl Zeiss Meditec, Inc.5160 Hacienda Drivedublin, CA 94568 PMA NumberP150040 Supplement NumberS010 Date Received05/23/2022 Decision Date06/17/2022 Product Code OTL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-23
Decision Date2022-06-17
PMAP150040
SupplementS010
Product CodeOTL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCarl Zeiss Meditec, Inc.
5160 Hacienda Drive
dublin, CA 94568 PMA NumberP150040 Supplement NumberS010 Date Received05/23/2022 Decision Date06/17/2022 Product Code OTL  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Replace The Type Of UV Light And The Supplier Of The UV Light Chamber For The Treatment Pack Accessory For The VisuMax Femtosecond Laser

Supplemental Filings

Supplement NumberDateSupplement Type
P150040Original Filing
S010 2022-05-23 30-day Notice
S009 2021-01-25 30-day Notice
S008 2020-11-19 Normal 180 Day Track
S007 2020-10-29 30-day Notice
S006 2020-09-08 30-day Notice
S005 2020-03-20 30-day Notice
S004 2018-12-11 Normal 180 Day Track No User Fee
S003 2018-03-23 Panel Track
S002 2018-02-28 Real-time Process
S001 2017-01-06 Real-time Process

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