PMA P930016S067
- Device
- iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- Product code
- LZS
- Decision date
- 2024-08-09
- Generic name
- Excimer laser system
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P930016/S053.
Current openFDA PMA Record
- Device
- iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S067
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2024-08-09
- Decision code
- APPR
- Date received
- 2024-07-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P930016/S053.