PMA P150040S014
- Device
- VisuMax Femtosecond Laser Accessory– Treatment Pack
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S014
- Product code
- OTL
- Decision date
- 2023-08-15
- Classification
- Ophthalmic
- Generic name
- Femtosecond laser system for refractive correction
- Approval order statement
- Second clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site.
Current openFDA PMA Record#
- Device
- VisuMax Femtosecond Laser Accessory– Treatment Pack
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P150040
- Supplement
- S014
- Product code
- OTL
- Generic name
- Femtosecond laser system for refractive correction
- Decision date
- 2023-08-15
- Decision code
- OK30
- Date received
- 2023-07-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second clean room for the manufacture of the Treatment Pack Accessory at the Jena, Germany manufacturing site.