PMA P150040S005

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S005
Product code
OTL
Decision date
2020-04-02
Generic name
Femtosecond laser system for refractive correction
Approval order statement
Secondary supplier for the Patient Support System (PSS).

Current openFDA PMA Record#

Device
VisuMax Femtosecond Laser
Applicant
Carl Zeiss Meditec, Inc.
PMA number
P150040
Supplement
S005
Product code
OTL
Generic name
Femtosecond laser system for refractive correction
Decision date
2020-04-02
Decision code
OK30
Date received
2020-03-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Secondary supplier for the Patient Support System (PSS).