PMA P930016S061
- Device
- iDESIGN Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S061
- Product code
- LZS
- Decision date
- 2020-02-14
- Generic name
- Excimer laser system
- Approval order statement
- Approval for a replacement of a Super Luminescent Diode (SLD) used in the iDESIGN Refractive Studio as a replacement for an SLD that is now obsolete.
Current openFDA PMA Record#
- Device
- iDESIGN Refractive Studio
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S061
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2020-02-14
- Decision code
- APPR
- Date received
- 2019-11-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a replacement of a Super Luminescent Diode (SLD) used in the iDESIGN Refractive Studio as a replacement for an SLD that is now obsolete.