FDA 510(k)

冰冷却IPL家用脱毛设备（型号：T10B，T10C，T15A，T17A，T18A，T14A，T16A，T19A）

K号: K241106 · 2024-05-22

申请人Shenzhen Mlay Intelligent Technology Co., , Ltd.

决定日期2024-05-22

产品代码OHT

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决定实质等同

器械摘要

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Mlay Intelligent Technology Co., , Ltd.. It received FDA 510(k) clearance on 2024-05-22 under 510(k) number K241106. 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 Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) is a medical device that received FDA 510(k) clearance on 2024-05-22. The listed applicant is Shenzhen Mlay Intelligent Technology Co., , Ltd.. The 510(k) number is K241106.

When did Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) receive FDA 510(k) clearance?

Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) received FDA 510(k) clearance on 2024-05-22, under 510(k) number K241106.

Who is the listed applicant for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

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

What is the FDA product code for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)?

The FDA product code for Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) is OHT.

列明Shenzhen Mlay Intelligent 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。

K253666IPL脱毛设备（型号：T31A, T32A）K251176IPL脱毛设备（型号：T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C）K240264家用脱毛设备（型号：T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A）

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。

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