PMA P150040S012
- Device
- VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S012
- Product code
- OTL
- Decision date
- 2024-01-10
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- for design changes to the VISUMAX 800.
Current openFDA PMA Record#
- Device
- VISUMAX 800
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S012
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2024-01-10
- Decision code
- APPR
- Date received
- 2022-12-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- for design changes to the VISUMAX 800.