FDA 510(k)

Laser Cap, Model: Hat-01

Número K: K232356 · 2023-10-24

Data da decisão2023-10-24

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Laser Cap, Model: Hat-01 is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Yjt Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-10-24 under 510(k) number K232356. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Laser Cap, Model: Hat-01?

Laser Cap, Model: Hat-01 is a medical device that received FDA 510(k) clearance on 2023-10-24. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K232356.

When did Laser Cap, Model: Hat-01 receive FDA 510(k) clearance?

Laser Cap, Model: Hat-01 received FDA 510(k) clearance on 2023-10-24, under 510(k) number K232356.

Who is the listed applicant for Laser Cap, Model: Hat-01?

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

What is the FDA product code for Laser Cap, Model: Hat-01?

The FDA product code for Laser Cap, Model: Hat-01 is OAP.

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Outros registros que listam Hubei Yjt Technology Co.,Ltd como candidato(a)

K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

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.

Fonte oficial

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