FDA 510(k)

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

Numéro K : K260899 · 2026-06-16

DemandeurZdeer Technology (Henan) Co., Ltd.

Date de décision2026-06-16

Code produitOAP

Comité consultatifPM

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Zdeer Technology (Henan) Co., Ltd. en tant que demandeur

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)

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 K251684Alma TED+ SystemAlma Lasers, Inc.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.