FDA 510(k)

Diamond Air+ (UI04A, UI04B, UI04C)

K号: K221553 · 2022-09-15

决定日期2022-09-15

产品代码OHT

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决定实质等同

器械摘要

Diamond Air+ (UI04A, UI04B, UI04C) is the device name listed in this FDA 510(k) record. The listed applicant is Ulike Co., Ltd.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K221553. 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 Diamond Air+ (UI04A, UI04B, UI04C)?

Diamond Air+ (UI04A, UI04B, UI04C) is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Ulike Co., Ltd.. The 510(k) number is K221553.

When did Diamond Air+ (UI04A, UI04B, UI04C) receive FDA 510(k) clearance?

Diamond Air+ (UI04A, UI04B, UI04C) received FDA 510(k) clearance on 2022-09-15, under 510(k) number K221553.

Who is the listed applicant for Diamond Air+ (UI04A, UI04B, UI04C)?

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

What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C)?

The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C) is OHT.

列明Ulike 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。

K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)K213558IPL脱毛仪

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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