510(k) K181662 ยท GEX Powered Laser Surgical Instrument
Iridex TruFocus LIO Premiere
| Applicant | Iridex Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 5, 2018 |
| Received | Jun 25, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181662
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.