# K150409: VIVACE Electrosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Sung Hwan E&B Co.,Ltd
- Decided: Jan 15, 2016 after 331 days
- Product code: OUH (Skin Resurfacing Rf Applicator)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K943450 (1995). 24 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 4.

## Most influential descendants
- K193070: VIVACE Electrosurgical Device (2021), 4 descendants of its own
- K202415: VirtueRF (2021), 3 descendants of its own
- K211562: Virtue RF (2021), 2 descendants of its own
- K230968: VYBE RF Electrosurgical System (2023), 1 descendant of its own
- K262364: Ellian Enigma RF Device (2026), 0 descendants of its own

## Recalls of this device
- Mar 13, 2020 · Class II · Z-0444-2021: A high frequency output (2 MHz) has not been cleared for distribution in the U.S.

## 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. This Vivace Electrosurgical System is intended for use with Skin Type I to Skin Type V.

Source page: https://510kreport.com/device/K150409
Methodology: https://510kreport.com/methodology