PMA P150040S011
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S011
- Product code
- OTL
- Decision date
- 2022-12-21
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Qualify an additional manufacturing site for the supplier of the Contact Glass used in the Treatment Pack accessory.
Current openFDA PMA Record#
- Device
- VisuMax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S011
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2022-12-21
- Decision code
- OK30
- Date received
- 2022-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify an additional manufacturing site for the supplier of the Contact Glass used in the Treatment Pack accessory.