510(k) K203241 ยท GEX Powered Laser Surgical Instrument
OmniGuide BeamPath OTO-U Fiber
| Applicant | Omniguide, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Jan 14, 2021 |
| Received | Nov 3, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203241
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.