Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Home use hair removal device, model: Precise Touch Pro

N.º K: K213830 · 2022-02-01

SolicitanteIluminage Beauty Co., Limited
Fecha de decisión2022-02-01
Código de productoOHT
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Home use hair removal device, model: Precise Touch Pro is the device name listed in this FDA 510(k) record. The listed applicant is Iluminage Beauty Co., Limited. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K213830. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Home use hair removal device, model: Precise Touch Pro?

Home use hair removal device, model: Precise Touch Pro is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Iluminage Beauty Co., Limited. The 510(k) number is K213830.

When did Home use hair removal device, model: Precise Touch Pro receive FDA 510(k) clearance?

Home use hair removal device, model: Precise Touch Pro received FDA 510(k) clearance on 2022-02-01, under 510(k) number K213830.

Who is the listed applicant for Home use hair removal device, model: Precise Touch Pro?

The FDA 510(k) record lists Iluminage Beauty Co., Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Home use hair removal device, model: Precise Touch Pro?

The FDA product code for Home use hair removal device, model: Precise Touch Pro is OHT.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: OHT)

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.

K261977Braun Aura 9 (6042)Cyden LimitedK262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics 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.

↑