510(k) K161885 ยท OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
The Cellfina System
| Applicant | Ulthera, Inc., Mesa AZ, US |
| Decision | Substantially Equivalent, Oct 5, 2016 |
| Received | Jul 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2016 | Ulthera Inc Cellfina Prep Pack, Part No. CP1 Terminated |
OUP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.