FDA 510(k)

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

Número K: K230134 · 2023-05-23

Data da decisão2023-05-23

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

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)K232356Laser Cap, Model: Hat-01

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

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.