PMA P060004S004
- Device
- MEL 80 Excimer Laser System
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S004
- Product code
- LZS
- Decision date
- 2023-02-16
- Classification
- Ophthalmic
- Generic name
- Excimer laser system
- Approval order statement
- Change the coating of the d24 VIS Window component of the laser.
Current openFDA PMA Record#
- Device
- MEL 80 Excimer Laser System
- Applicant
- Carl Zeiss Meditec, Inc.
- PMA number
- P060004
- Supplement
- S004
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2023-02-16
- Decision code
- OK30
- Date received
- 2023-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the coating of the d24 VIS Window component of the laser.