510(k) clearance
Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)
- 510(k) number
- K243223
- Applicant
- Bh Group Us, LLC
- Decision date
- Sep 22, 2026
- Date received
- Oct 7, 2024
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PBX
- Device type
- Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II
- Regulation
- 21 CFR 878.4400
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Davie, FL, US