Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)— 510(k) K243223
Substantially EquivalentBh Group Us, LLC
FDA 510(k) clearance K243223 for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE), Substantially Equivalent on 2026-09-22. Applicant: Bh Group Us, LLC. Device class: 2.
Summary
The BHS 202 UNYQUE, described in the record as a multiple therapy aesthetic treatment device, is filed under PBX: vacuum massagers with radio frequency induced heat. The record doesn't list the specific therapies or indications.
Class II, 21 CFR 878.4400. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Bh Group Us, LLC filed from Davie, Florida. The clock ran 715 days, from October 7, 2024 to September 22, 2026. That's nearly two years, and the record doesn't say why.
Clearance details
- Applicant
- Bh Group Us, LLC
- Product code
- Product code PBX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davie, FL, US
Recent devices under product code PBX
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