510(k) K180993 ยท GEX Powered Laser Surgical Instrument
Beacon Advanced CO2 Laser System
| Applicant | Omniguide, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Jun 28, 2018 |
| Received | Apr 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180993
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.