PMA P150040S017
- Device
- VisuMax
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S017
- Product code
- OTL
- Decision date
- 2024-05-23
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- an additional third clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site
Current openFDA PMA Record#
- Device
- VisuMax
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S017
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2024-05-23
- Decision code
- OK30
- Date received
- 2024-04-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional third clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site