PMA P150040S008

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S008
Product code
OTL
Decision date
2021-02-19
Generic name
Femtosecond laser system for refractive correction
Approval order statement
Approval of obsolescence and life-cycle changes of hardware, software, and electronics.

Current openFDA PMA Record#

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S008
Product code
OTL
Generic name
Femtosecond laser system for refractive correction
Decision date
2021-02-19
Decision code
APPR
Date received
2020-11-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval of obsolescence and life-cycle changes of hardware, software, and electronics.