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FDA 510(k)

Laser Hair Growth Cap

N.º K: K192627 · 2019-12-13

SolicitanteShang FA Biotechnology Co.
Fecha de decisión2019-12-13
Código de productoOAP
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser Hair Growth Cap is the device name listed in this FDA 510(k) record. The listed applicant is Shang FA Biotechnology Co.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K192627. 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 Laser Hair Growth Cap?

Laser Hair Growth Cap is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shang FA Biotechnology Co.. The 510(k) number is K192627.

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

Laser Hair Growth Cap received FDA 510(k) clearance on 2019-12-13, under 510(k) number K192627.

Who is the listed applicant for Laser Hair Growth Cap?

The FDA 510(k) record lists Shang FA Biotechnology Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser Hair Growth Cap?

The FDA product code for Laser Hair Growth Cap 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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