PMA P150040S023
- Device
- VISUMAX 800 Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S023
- Product code
- OTL
- Decision date
- 2025-10-16
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- adding a new production diagnostic tool for the VISUMAX 800 Femtosecond Laser scan system
Current openFDA PMA Record#
- Device
- VISUMAX 800 Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S023
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2025-10-16
- Decision code
- OK30
- Date received
- 2025-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding a new production diagnostic tool for the VISUMAX 800 Femtosecond Laser scan system