FDA 510(k)

冰冷光療家用除毛設備 (型號：T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A)

K 號：K241106 · 2024-05-22

申請人Shenzhen Mlay Intelligent Technology Co., , Ltd.

決定日期2024-05-22

產品代碼OHT

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shenzhen Mlay Intelligent Technology Co., , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253666IPL 髮毛去除器（型號：T31A、T32A）K251176IPL 髮毛去除器（型號：T14B、T16B、T19B、T15B、T17C、T18B、T21A、T21B、T21C、T21D、T22A、T22B、T25B、T25C）K240264家用除毛設備（型號：T10A、T10B、T10C、T10D、T11A、T15A、T17A、T18A、T14A、T16A、T19A）

相關器械（代碼：OHT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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