510(k) K162398 ยท ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
CO2 Laser Therapy Systems
| Applicant | Beijing Sincoheren Science and Technology Development Co., Beijing, CN |
| Decision | Substantially Equivalent, Jul 6, 2017 |
| Received | Aug 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162398
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.