PMA P150040S016
- Device
- VisuMax
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S016
- Product code
- OTL
- Decision date
- 2024-10-11
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- an additional supplier for the contact glass of the Treatment Pack.
Current openFDA PMA Record#
- Device
- VisuMax
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S016
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2024-10-11
- Decision code
- APPR
- Date received
- 2024-04-19
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for the contact glass of the Treatment Pack.