FDA 510(k)

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

K-Nummer: K243223 · 2026-09-22

Entscheidungsdatum2026-09-22

ProduktcodePBX

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) is the device name listed in this FDA 510(k) record. The listed applicant is Bh Group Us, LLC. It received FDA 510(k) clearance on 2026-09-22 under 510(k) number K243223. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)?

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) is a medical device that received FDA 510(k) clearance on 2026-09-22. The listed applicant is Bh Group Us, LLC. The 510(k) number is K243223.

When did Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) receive FDA 510(k) clearance?

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) received FDA 510(k) clearance on 2026-09-22, under 510(k) number K243223.

Who is the listed applicant for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)?

The FDA 510(k) record lists Bh Group Us, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)?

The FDA product code for Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) is PBX.

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Verwandte Geräte (Code: PBX)

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

Offizielle Quelle

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