# K243223: Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

- Pathway: 510(k) (Traditional)
- Applicant: Bh Group Us, LLC
- Decided: Sep 22, 2026 after 715 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- 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: 20 generations back to K943450 (1995). 314 ancestors in all.
No later device cites it as a predicate yet.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202780: Sectum, Neauvia North America (2021) Summary page 5.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 5.

## Indications for use
The multi-therapy aesthetic treatment device is designed to apply cold and radiofrequency. Radiofrequency hand piece raises tissue temperature to treat specific medical conditions, including relieving pain, relieving muscle spasms, improving local blood circulation, and temporarily improving the appearance of cellulite. The multi-therapy aesthetic treatment device is intended for prescription use only, as defined in 21 CFR 801 Subpart D.

Source page: https://510kreport.com/device/K243223
Methodology: https://510kreport.com/methodology