# K193070: VIVACE Electrosurgical Device

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Apr 26, 2021 after 539 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 25 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150409: VIVACE Electrosurgical System, Sung Hwan E&B Co.,Ltd (2016) Summary page 5.

## Most influential descendants
- K230968: VYBE RF Electrosurgical System (2023), 1 descendant of its own
- K262364: Ellian Enigma RF Device (2026), 0 descendants of its own
- K241535: Vybe RF II (2024), 0 descendants of its own
- K233120: CWM-930S, Fixer DV9 (2024), 0 descendants of its own

## Indications for use
The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the IMHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K193070
Methodology: https://510kreport.com/methodology