FDA 510(k)

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

N.º K: K260899 · 2026-06-16

SolicitanteZdeer Technology (Henan) Co., Ltd.

Fecha de decisión2026-06-16

Código de productoOAP

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is the device name listed in this FDA 510(k) record. The listed applicant is Zdeer Technology (Henan) Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K260899. 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 Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Zdeer Technology (Henan) Co., Ltd.. The 510(k) number is K260899.

When did Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) receive FDA 510(k) clearance?

Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K260899.

Who is the listed applicant for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

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

What is the FDA product code for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)?

The FDA product code for Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) is OAP.

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Otros registros que enlistan a Zdeer Technology (Henan) Co., Ltd. como solicitante

K260452Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158)

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 K251684Alma TED+ SistemaAlma Lasers, Inc.

Fuente oficial

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