FDA 510(k)

手持式IPL设备（JOVS石墨烯脱毛设备）

K号: K214113 · 2022-03-28

决定日期2022-03-28

产品代码OHT

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决定实质等同

器械摘要

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.

常见问题

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)?

FDA 510(k)记录将深圳前域科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明Shenzhen Qianyu Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261851LED光疗面罩（JML1，JML1+JML2）；LED光疗面罩（JML3，JML3+JML4）；LED光疗面罩（JML5，JML5+JML7）；LED光疗面罩（JML6，JML6+JML8）；LED光疗面罩（JML9，JML9+JML10）K250227JOVS电刺激美容设备（JE2）K244020皱纹治疗设备（JM1，JM2B）K240360皱纹治疗设备（JM2）K231800IPL脱毛设备，型号：JP1, JR3, JR8, JR9 K220645手持式IPL设备（JOVS脱毛设备）

查看所有 7 个设备 →

相关器械（代码：OHT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261977Braun Aura 9（6042）Cyden Limited K262524蓝宝石冷却IPL脱毛设备（冰2.0，冰2.1，冰2.2，冰2.0B，冰2.1B，冰2.2B）ONE BEAUTY Technology Co., Ltd.K261705脱毛设备（R3C16-G Pro，R3C16-V Pro）Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325冰冷却IPL脱毛设备（UI06S PR，UI06S PN，UI06S WH，UI06S PRU，UI06S PNU，UI06S WHU）Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL脱毛仪（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.K260742冰冷却IPL脱毛设备（UI20S DB，UI20S RE，UI20S PW，UI20S GP，UI20S GR，UI20S BK）Shenzhen Ulike Smart Electronics Co., Ltd.

官方来源

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