# K202415: VirtueRF

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Jan 22, 2021 after 151 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.
3 later devices descend from it; 1 cites it directly.
0 of 29 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
- K211562: Virtue RF (2021), 2 descendants of its own
- K251836: Dermatrix Duo (2026), 0 descendants of its own
- K241535: Vybe RF II (2024), 0 descendants of its own

## Indications for use
The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz. 1MHz Indications for use Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V. 2MHz Indications for use Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.

Source page: https://510kreport.com/device/K202415
Methodology: https://510kreport.com/methodology