FDA 510(k)

IPL Cooling Hair Removal Device

N.º K: K232845 · 2023-11-14

SolicitanteShenzhen Siken 3D Technology Development Co., Ltd.

Fecha de decisión2023-11-14

Código de productoOHT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

IPL Cooling Hair Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K232845. 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 Cooling Hair Removal Device?

IPL Cooling Hair Removal Device is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Shenzhen Siken 3D Technology Development Co., Ltd.. The 510(k) number is K232845.

When did IPL Cooling Hair Removal Device receive FDA 510(k) clearance?

IPL Cooling Hair Removal Device received FDA 510(k) clearance on 2023-11-14, under 510(k) number K232845.

Who is the listed applicant for IPL Cooling Hair Removal Device?

The FDA 510(k) record lists Shenzhen Siken 3D Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Cooling Hair Removal Device?

The FDA product code for IPL Cooling Hair Removal Device is OHT.

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Otros registros que enlistan a Shenzhen Siken 3D Technology Development Co., Ltd. como solicitante

K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)K252142Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)K243040LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)K222710IPL Cooling Hair Removal Device K163470Galvanic Spa, Model: SKB-1405

Dispositivos relacionados (Código: OHT)

K261977Braun Aura 9 (6042)Cyden Limited K262524Sapphire 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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