VisuMax Femtosecond Laser

FDA Premarket Approval P150040 S008

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

Approval of obsolescence and life-cycle changes of hardware, software, and electronics.

DeviceVisuMax Femtosecond Laser
Generic NameFemtosecond Laser System For Refractive Correction
ApplicantCarl Zeiss Meditec, Inc.
Date Received2020-11-19
Decision Date2021-02-19
PMAP150040
SupplementS008
Product CodeOTL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568

Supplemental Filings

Supplement NumberDateSupplement Type
P150040Original Filing
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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