510(k) K170718 ยท GEX Powered Laser Surgical Instrument
Iridex TruFocus LIO Premiere
| Applicant | Iridex Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, May 3, 2017 |
| Received | Mar 9, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170718
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | Iridex Corporation Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO )
The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a pat Terminated |
GEX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.