PMA P930016S063
- Device
- iDesign Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- Product code
- LZS
- Decision date
- 2023-10-16
- Generic name
- Excimer laser system
- Approval order statement
- new suppliers for cable and mounting arm components of the iDESIGN
Current openFDA PMA Record#
- Device
- iDesign Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S063
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2023-10-16
- Decision code
- OK30
- Date received
- 2023-09-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new suppliers for cable and mounting arm components of the iDESIGN