FDA 510(k)

Hair Regrowth Cap (Model: T-119-HRC)

N.º K: K253349 · 2025-12-24

SolicitanteLight Tree Ventures Europe B.V.

Fecha de decisión2025-12-24

Código de productoOAP

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hair Regrowth Cap (Model: T-119-HRC) is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253349. 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 Hair Regrowth Cap (Model: T-119-HRC)?

Hair Regrowth Cap (Model: T-119-HRC) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K253349.

When did Hair Regrowth Cap (Model: T-119-HRC) receive FDA 510(k) clearance?

Hair Regrowth Cap (Model: T-119-HRC) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253349.

Who is the listed applicant for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Regrowth Cap (Model: T-119-HRC)?

The FDA product code for Hair Regrowth Cap (Model: T-119-HRC) is OAP.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Otros registros que enlistan a Light Tree Ventures Europe B.V. como solicitante

K260415myLEDmask 2 (MJ-144)K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 K223893Infrared Heat (Model: E0221)K230597Aduro Comb (Modelo: SZ-22, SZ-22A, SZ-22B)K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)

Ver todos los 13 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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.