# K230968: VYBE RF Electrosurgical System

- Pathway: 510(k) (Special)
- Applicant: ShenB Co., Ltd.
- Decided: Jul 6, 2023 after 92 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.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193070: VIVACE Electrosurgical Device, ShenB Co., Ltd. (2021) Summary page 5.

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

## Indications for use
The VYBE RF 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 1MHz 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/K230968
Methodology: https://510kreport.com/methodology