# K241535: Vybe RF II

- Pathway: 510(k) (Traditional)
- Applicant: ShenB Co., Ltd.
- Decided: Sep 25, 2024 after 118 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: 14 generations back to K943450 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211562: Virtue RF, ShenB Co., Ltd. (2021) Summary page 5.
- K230968: VYBE RF Electrosurgical System, ShenB Co., Ltd. (2023). Our reading of the summary gave K230986, FDA’s number for Bladder Scanner (Avantsonic Technology Co., Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Vybe RF”.

## Indications for use
The VYBE RF II is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Microneedle Array Handpiece (1MHz): The Microneedle Array Handpiece with 1 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At power less than 36W, the Microneedle Array Handpiece with 1 MHz functionality is intended for the percutaneous treatment of facial wrinkles in Skin Types I-V. Microneedle Array Handpiece (2MHz): The Microneedle Array Handpiece with 2 MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Microneedle Array handpiece with 2MHz functionality is not intended to treat wrinkles. One Pin Exact Handpiece: The One Pin Exact handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The One Pin Exact Handpiece is not intended to treat wrinkles.

Source page: https://510kreport.com/device/K241535
Methodology: https://510kreport.com/methodology