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FDA 510(k)

IPL Hair Removal, Model: OBT-02

Número K: K213041 · 2021-11-18

RequerenteGlan Electronics Co., Ltd.
Data da decisão2021-11-18
Código do produtoOHT
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

IPL Hair Removal, Model: OBT-02 is the device name listed in this FDA 510(k) record. The listed applicant is Glan Electronics Co., Ltd.. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K213041. 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 Hair Removal, Model: OBT-02?

IPL Hair Removal, Model: OBT-02 is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Glan Electronics Co., Ltd.. The 510(k) number is K213041.

When did IPL Hair Removal, Model: OBT-02 receive FDA 510(k) clearance?

IPL Hair Removal, Model: OBT-02 received FDA 510(k) clearance on 2021-11-18, under 510(k) number K213041.

Who is the listed applicant for IPL Hair Removal, Model: OBT-02?

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

What is the FDA product code for IPL Hair Removal, Model: OBT-02?

The FDA product code for IPL Hair Removal, Model: OBT-02 is OHT.

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Dispositivos Relacionados (Código: OHT)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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.

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