PMA P150040S025
- Device
- Visumax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S025
- Product code
- OTL
- Decision date
- 2026-05-20
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- a change to an in-process quality control parameter for creep testing
Current openFDA PMA Record#
- Device
- Visumax Femtosecond Laser
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S025
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2026-05-20
- Decision code
- OK30
- Date received
- 2026-04-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to an in-process quality control parameter for creep testing