FDA 510(k)

IPL sapphire ice cooling hair remove device

Número K: K221635 · 2022-08-31

RequerenteShenzhen Desida Technology Co., Ltd.

Data da decisão2022-08-31

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

IPL sapphire ice cooling hair remove device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Desida Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-31 under 510(k) number K221635. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IPL sapphire ice cooling hair remove device?

IPL sapphire ice cooling hair remove device is a medical device that received FDA 510(k) clearance on 2022-08-31. The listed applicant is Shenzhen Desida Technology Co., Ltd.. The 510(k) number is K221635.

When did IPL sapphire ice cooling hair remove device receive FDA 510(k) clearance?

IPL sapphire ice cooling hair remove device received FDA 510(k) clearance on 2022-08-31, under 510(k) number K221635.

Who is the listed applicant for IPL sapphire ice cooling hair remove device?

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

What is the FDA product code for IPL sapphire ice cooling hair remove device?

The FDA product code for IPL sapphire ice cooling hair remove device is OHT.

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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.

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