PMA P930016S060
- Device
- iDESIGN Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S060
- Product code
- LZS
- Decision date
- 2020-01-28
- Generic name
- Excimer laser system
- Approval order statement
- Approval for four (4) minor software changes to the iDESJGN Refractive Studio.
Current openFDA PMA Record#
- Device
- iDESIGN Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S060
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2020-01-28
- Decision code
- APPR
- Date received
- 2019-10-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for four (4) minor software changes to the iDESJGN Refractive Studio.