FDA 510(k)

Laser hair growth helmet

N.º K: K213025 · 2022-05-12

SolicitanteKam Yuen Plastic Products , Ltd.

Fecha de decisión2022-05-12

Código de productoOAP

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser hair growth helmet is the device name listed in this FDA 510(k) record. The listed applicant is Kam Yuen Plastic Products , Ltd.. It received FDA 510(k) clearance on 2022-05-12 under 510(k) number K213025. 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 helmet?

Laser hair growth helmet is a medical device that received FDA 510(k) clearance on 2022-05-12. The listed applicant is Kam Yuen Plastic Products , Ltd.. The 510(k) number is K213025.

When did Laser hair growth helmet receive FDA 510(k) clearance?

Laser hair growth helmet received FDA 510(k) clearance on 2022-05-12, under 510(k) number K213025.

Who is the listed applicant for Laser hair growth helmet?

The FDA 510(k) record lists Kam Yuen Plastic Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Laser hair growth helmet?

The FDA product code for Laser hair growth helmet is OAP.

Ensayos clínicos relacionados

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Otros registros que enlistan a Kam Yuen Plastic Products , Ltd. como solicitante

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)K230107Aimanfun Lumea Comfort, Modelo: A-2788, A-2789 y A-3588 K213027Laser Hair Growth Comb K212907Aimanfun Lumea Comfort, A-2789/A-3588 K190820Aimanfun Lumea Comfort

Dispositivos relacionados (Código: OAP)

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.,Ltd K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.

Fuente oficial

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