IPL脱毛仪
K号: K212318 · 2022-01-14
广告
决定日期2022-01-14
产品代码OHT
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
IPL Hair Removal is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Define Beauty Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K212318. 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 IPL Hair Removal?
IPL Hair Removal is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Dongguan Define Beauty Electronic Technology Co., Ltd.. The 510(k) number is K212318.
When did IPL Hair Removal receive FDA 510(k) clearance?
IPL Hair Removal received FDA 510(k) clearance on 2022-01-14, under 510(k) number K212318.
Who is the listed applicant for IPL Hair Removal?
The FDA 510(k) record lists Dongguan Define Beauty Electronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IPL Hair Removal?
The FDA product code for IPL Hair Removal is OHT.
相关临床试验
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。
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 LimitedK262524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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
广告