PMA P150040S006

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S006
Product code
OTL
Decision date
2020-10-07
Generic name
Femtosecond laser system for refractive correction
Approval order statement
Additional supplier for the Treatment Pack contact glass lens.

Current openFDA PMA Record#

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S006
Product code
OTL
Generic name
Femtosecond laser system for refractive correction
Decision date
2020-10-07
Decision code
OK30
Date received
2020-09-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Additional supplier for the Treatment Pack contact glass lens.