PMA P150040S024
- Device
- VISUMAX 800 Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S024
- Product code
- OTL
- Decision date
- 2026-05-26
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- design changes to the laser sources to address temperature-induced laser beam drift
Current openFDA PMA Record#
- Device
- VISUMAX 800 Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S024
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2026-05-26
- Decision code
- APPR
- Date received
- 2026-02-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- design changes to the laser sources to address temperature-induced laser beam drift