510(k) K161043 ยท PBX Massager, Vacuum, Radio Frequency Induced Heat
Profound System
| Applicant | Syneron Candela Corporation, Wayland MA, US |
| Decision | Substantially Equivalent, Sep 12, 2016 |
| Received | Apr 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161043
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.