VisuMax Femtosecond Laser

FDA Premarket Approval P150040 S006

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

An additional supplier for the treatment pack contact glass lens

DeviceVisuMax Femtosecond Laser
Generic NameFemtosecond Laser System For Refractive Correction
ApplicantCarl Zeiss Meditec, Inc.
Date Received2020-09-08
Decision Date2020-10-07
Product CodeOTL 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Carl Zeiss Meditec, Inc. 5160 Hacienda Drive dublin, CA 94568

Supplemental Filings

Supplement NumberDateSupplement Type
P150040Original Filing
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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