PMA P150040S009

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S009
Product code
OTL
Decision date
2021-02-24
Generic name
Femtosecond laser system for refractive correction
Approval order statement
Alternate contract sterilizer for the Treatment Pack accessory.

Current openFDA PMA Record#

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S009
Product code
OTL
Generic name
Femtosecond laser system for refractive correction
Decision date
2021-02-24
Decision code
OK30
Date received
2021-01-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Alternate contract sterilizer for the Treatment Pack accessory.