FDA 510(k)

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

Numéro K : K230134 · 2023-05-23

Date de décision2023-05-23

Code produitOAP

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 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 2023-05-23 under 510(k) number K230134. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 is a medical device that received FDA 510(k) clearance on 2023-05-23. The listed applicant is Hubei Yjt Technology Co.,Ltd. The 510(k) number is K230134.

When did Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 receive FDA 510(k) clearance?

Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 received FDA 510(k) clearance on 2023-05-23, under 510(k) number K230134.

Who is the listed applicant for Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

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 Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002?

The FDA product code for Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 is OAP.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Hubei Yjt Technology Co.,Ltd en tant que demandeur

K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)K232356Laser Cap, Model: Hat-01

Dispositifs connexes (Code : 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.

Source officielle

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