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FDA 510(k)

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)

N.º K: K242197 · 2024-10-17

SolicitanteShenzhen Huaruibo Electric Appliances Co., Ltd.
Fecha de decisión2024-10-17
Código de productoOHT
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Huaruibo Electric Appliances Co., Ltd.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K242197. 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 IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Shenzhen Huaruibo Electric Appliances Co., Ltd.. The 510(k) number is K242197.

When did IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) receive FDA 510(k) clearance?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K242197.

Who is the listed applicant for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

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

What is the FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

The FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is OHT.

Ensayos clínicos relacionados

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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

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