510(k) K182270 ยท GEX Powered Laser Surgical Instrument
Cellene CO2 Laser System
| Applicant | Bio-Med USA, Inc., Ramsey NJ, US |
| Decision | Substantially Equivalent, Nov 2, 2018 |
| Received | Aug 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182270
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.