510(k) K160195 ยท ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Forma System, Forma Light System
| Applicant | Formatk Systems , Ltd., Tirat Carmel, IL |
| Decision | Substantially Equivalent, Apr 15, 2016 |
| Received | Jan 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160195
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.