PMA P150040S021
- Device
- Visumax; VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S021
- Product code
- OTL
- Decision date
- 2025-08-21
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- approval of a new supplier for the slider component of the OPMI arm of the VISUMAX 800 Femtosecond Laser
Current openFDA PMA Record#
- Device
- Visumax; VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S021
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2025-08-21
- Decision code
- OK30
- Date received
- 2025-07-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of a new supplier for the slider component of the OPMI arm of the VISUMAX 800 Femtosecond Laser