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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K243223

510(k) cleared

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

Bh Group Us, LLC · Sep 22, 2026 · K243223

FDA cleared the Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) from Bh Group Us, LLC on Sep 22, 2026 under K243223, a traditional 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Oct 7, 2024. The decision came 715 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Bh Group Us, LLC has 8 other decisions in the tracker over the last 12 months: K254260 (The VEGA Cervical Screw System), K262202 (Cerasmart Forte), K262828 (KHEIRON® Spinal Fixation System, including patient specific K-ROD), DEN250043 (Qoramatic Automated Stool Management).

Questions & Answers

What did FDA clear under K243223?

K243223 is the FDA 510(k) for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE), submitted by Bh Group Us, LLC. FDA's decision date was Sep 22, 2026, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)?

Bh Group Us, LLC, based in Davie, FL, is the applicant of record for K243223.

How long did the K243223 review take?

FDA received the submission on Oct 7, 2024 and issued its decision on Sep 22, 2026, 715 days later.

← All decisions in September 2026