510(k) K162163 ยท OHV Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
UltraShape System
| Applicant | Syneron Medical, Ltd., Yokneam Illit, IL |
| Decision | Substantially Equivalent, Nov 17, 2016 |
| Received | Aug 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162163
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.