FDA 510(k)

Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)

Número K: K243223 · 2026-09-22

Data da decisão2026-09-22

Código do produtoPBX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos Relacionados (Código: PBX)

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Quattro Apollo (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.