FDA 510(k)

Hand-held IPL device(JOVS Graphene Hair Removal Device)

N.º K: K214113 · 2022-03-28

SolicitanteShenzhen Qianyu Technology Co., Ltd.

Fecha de decisión2022-03-28

Código de productoOHT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Hand-held IPL device(JOVS Graphene Hair Removal Device) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-03-28 under 510(k) number K214113. 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 Hand-held IPL device(JOVS Graphene Hair Removal Device)?

Hand-held IPL device(JOVS Graphene Hair Removal Device) is a medical device that received FDA 510(k) clearance on 2022-03-28. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. The 510(k) number is K214113.

When did Hand-held IPL device(JOVS Graphene Hair Removal Device) receive FDA 510(k) clearance?

Hand-held IPL device(JOVS Graphene Hair Removal Device) received FDA 510(k) clearance on 2022-03-28, under 510(k) number K214113.

Who is the listed applicant for Hand-held IPL device(JOVS Graphene Hair Removal Device)?

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

What is the FDA product code for Hand-held IPL device(JOVS Graphene Hair Removal Device)?

The FDA product code for Hand-held IPL device(JOVS Graphene Hair Removal Device) is OHT.

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Otros registros que enlistan a Shenzhen Qianyu Technology Co., Ltd. como solicitante

K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)K250227JOVS Electric Stimulation Beauty Device (JE2)K244020Wrinkle Treatment Device (JM1, JM2B)K240360Wrinkle Treatment Device (JM2)K231800IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 K220645Hand-held IPL device (JOVS Hair Removal Device)

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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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