FDA 510(k)

HIGHERDOSE Red Light Hat (HG-120K)

Número K: K242363 · 2024-11-20

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2024-11-20

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

HIGHERDOSE Red Light Hat (HG-120K) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K242363. 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 HIGHERDOSE Red Light Hat (HG-120K)?

HIGHERDOSE Red Light Hat (HG-120K) is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K242363.

When did HIGHERDOSE Red Light Hat (HG-120K) receive FDA 510(k) clearance?

HIGHERDOSE Red Light Hat (HG-120K) received FDA 510(k) clearance on 2024-11-20, under 510(k) number K242363.

Who is the listed applicant for HIGHERDOSE Red Light Hat (HG-120K)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIGHERDOSE Red Light Hat (HG-120K)?

The FDA product code for HIGHERDOSE Red Light Hat (HG-120K) 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 Shenzhen Kaiyan Medical Equipment Co., Ltd. como candidato(a)

K253932FACEGYM Pro Device (HD-109)K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)K252603HIGHERDOSE Body Sculptor (Modelo: GS-03)

Ver todos os 24 dispositivos →

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.