- Device
- iDesign Advanced WaveScan Studio, STAR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S062
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2021-02-26
- Decision code
- APPR
- Date received
- 2020-10-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of several minor clarifications and corrections to either define the original intent of the protocol, or correct mismatched information in the protocol