PMA P930016S052
- Device
- Star S4 IR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S052
- Product code
- LZS
- Decision date
- 2017-06-23
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- Changes to the acceptance criteria and the supplier of the beam splitter used in the STAR S4 IR Excimer Laser System.
Current openFDA PMA Record#
- Device
- Star S4 IR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S052
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2017-06-23
- Decision code
- OK30
- Date received
- 2017-06-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the acceptance criteria and the supplier of the beam splitter used in the STAR S4 IR Excimer Laser System.