PMA P930016S064
- Decision date
- 1969-12-31
Current openFDA PMA Record
- Device
- iDesign Refractive Studio (iDesign/G301)
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S064
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2024-03-21
- Decision code
- APPR
- Date received
- 2023-12-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Requested approval for a material change to the forehead strap and chin rest of the iDesign System (P930016/S053).