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FDA 510(k)

Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

N.º K: K250308 · 2025-04-29

SolicitanteDongguan Boyuan Intelligent Technology Co.,Ltd
Fecha de decisión2025-04-29
Código de productoOAP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2025-04-29 under 510(k) number K250308. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)?

Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) is a medical device that received FDA 510(k) clearance on 2025-04-29. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. The 510(k) number is K250308.

When did Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) receive FDA 510(k) clearance?

Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) received FDA 510(k) clearance on 2025-04-29, under 510(k) number K250308.

Who is the listed applicant for Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)?

The FDA 510(k) record lists Dongguan Boyuan Intelligent Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)?

The FDA product code for Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) is OAP.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Dongguan Boyuan Intelligent Technology Co.,Ltd como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K250253IPL Hair Removal Device (KCA511/KCA516/KCA522)K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)K240282IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)

Dispositivos relacionados (Código: OAP)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.K262254Hair Growth Comb (X-GC01)Guangdong Ashmore Health Technology Co., Ltd.K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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