The following data is part of a premarket notification filed by Sung Hwan E&b Co.,ltd with the FDA for Vivace Electrosurgical System.
| Device ID | K150409 |
| 510k Number | K150409 |
| Device Name: | VIVACE Electrosurgical System |
| Classification | Skin Resurfacing Rf Applicator |
| Applicant | Sung Hwan E&B Co.,Ltd SK Techno Bld Suite #502 ,16-4 Seongsu-Dong 1-Ga Seongdong-gu, KR 133710 |
| Contact | Sun Young Kang |
| Correspondent | Kachi Enyinna 510K Technology Group, LLC 263 Huntington Avenue, Suite #332 Boston, MA 02115 |
| Product Code | OUH |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-18 |
| Decision Date | 2016-01-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800017100326 | K150409 | 000 |
| 08800017100234 | K150409 | 000 |
| 08800017100722 | K150409 | 000 |
| 08800017100715 | K150409 | 000 |