# K211562: Virtue RF

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Nov 23, 2021 after 187 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: 13 generations back to K943450 (1995). 26 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K202415: VirtueRF, ShenB Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K251836: Dermatrix Duo (2026), 0 descendants of its own
- K241535: Vybe RF II (2024), 0 descendants of its own

## Indications for use
The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Smart RF Handpiece: The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V. The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles. Exact RF Handpiece: The Exact RF Handpiece with IMHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles. Deep RF Handpiece: The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with IMHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.

Source page: https://510kreport.com/device/K211562
Methodology: https://510kreport.com/methodology