PMA P990010S006
- Device
- STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P990010
- Supplement
- S006
- Product code
- LZS
- Decision date
- 2014-05-30
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order statement
- ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM.
Current openFDA PMA Record#
- Device
- STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P990010
- Supplement
- S006
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2014-05-30
- Decision code
- OK30
- Date received
- 2014-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A RE-POLISHING PROCESS FOR THE HEX PRISM ASSEMBLY, OF THE STAR SYSTEM.