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FDA 510(k)

Hair Growth System

N.º K: K191754 · 2019-11-22

SolicitanteKunshan Bella Optical Technology Co., Ltd.
Fecha de decisión2019-11-22
Código de productoOAP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Bella Optical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191754. 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 System?

Hair Growth System is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Kunshan Bella Optical Technology Co., Ltd.. The 510(k) number is K191754.

When did Hair Growth System receive FDA 510(k) clearance?

Hair Growth System received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191754.

Who is the listed applicant for Hair Growth System?

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

What is the FDA product code for Hair Growth System?

The FDA product code for Hair Growth System is OAP.

Ensayos clínicos relacionados

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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

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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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