510(k) K220189 ยท GEX Powered Laser Surgical Instrument
LISA Laser Surgical Fibers
| Applicant | Omni-Guide Holdings, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Apr 29, 2022 |
| Received | Jan 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220189
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.