510(k) K150409 ยท OUH Skin Resurfacing Rf Applicator
VIVACE Electrosurgical System
| Applicant | Sung Hwan E&B Co.,Ltd, Seongdong-Gu, KR |
| Decision | Substantially Equivalent, Jan 15, 2016 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150409
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2020 | Aesthetics Biomedical, Inc. SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous t Terminated |
OUH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.