510(k) K122389 ยท PBX Massager, Vacuum, Radio Frequency Induced Heat
TRUSCULPT
| Applicant | Cutera, Inc., Brisbane CA, US |
| Decision | Substantially Equivalent, Nov 2, 2012 |
| Received | Aug 7, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 9, 2013 | Cutera, Inc. Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA
The truSculpt massage device i Terminated |
OPT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.