510(k) K180189 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
InMode System with Fractora3D/3D-90 Applicators
| Applicant | Inmode MD , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Jun 1, 2018 |
| Received | Jan 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180189
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.