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FDA 510(k)

家用除毛設備(型號:T10A、T10B、T10C、T10D、T11A、T15A、T17A、T18A、T14A、T16A、T19A)

K 號:K240264 · 2024-03-08

決定日期2024-03-08
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

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, 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 2024-03-08 under 510(k) number K240264. 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 Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)?

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Shenzhen Mlay Intelligent Technology Co., , Ltd.. The 510(k) number is K240264.

When did Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) receive FDA 510(k) clearance?

Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K240264.

Who is the listed applicant for Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, 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 Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A)?

The FDA product code for Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) is OHT.

相關臨床試驗

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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。

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。

官方來源

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