FDA 510(k)

手持式脱毛设备（FZ-200A，FZ-201，FZ-202，CT05，CT06，CT07，CT08，CT09）

K号: K251000 · 2025-06-30

申请人Shenzhen Chuangtong Yigou Technology Co., Ltd.

决定日期2025-06-30

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

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-30 under 510(k) number K251000. 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 Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Shenzhen Chuangtong Yigou Technology Co., Ltd.. The 510(k) number is K251000.

When did Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) receive FDA 510(k) clearance?

Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) received FDA 510(k) clearance on 2025-06-30, under 510(k) number K251000.

Who is the listed applicant for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

FDA 510(k)记录将深圳创通易购科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)?

The FDA product code for Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) is OHT.

列明Shenzhen Chuangtong Yigou 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。

K261601LED光疗面罩（M01、M02、M03、M05、M06、M07、M08）K254047Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)

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

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。