510(k) K192695 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
InMode System with the Morpheus8 (Fractora) Applicators
| Applicant | Inmode MD , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, Dec 27, 2019 |
| Received | Sep 26, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192695
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.