FDA 510(k)

Diamond Air+ (UI04A, UI04B, UI04C)

K 號：K221553 · 2022-09-15

決定日期2022-09-15

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

Diamond Air+ (UI04A, UI04B, UI04C) is the device name listed in this FDA 510(k) record. The listed applicant is Ulike Co., Ltd.. It received FDA 510(k) clearance on 2022-09-15 under 510(k) number K221553. 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 Diamond Air+ (UI04A, UI04B, UI04C)?

Diamond Air+ (UI04A, UI04B, UI04C) is a medical device that received FDA 510(k) clearance on 2022-09-15. The listed applicant is Ulike Co., Ltd.. The 510(k) number is K221553.

When did Diamond Air+ (UI04A, UI04B, UI04C) receive FDA 510(k) clearance?

Diamond Air+ (UI04A, UI04B, UI04C) received FDA 510(k) clearance on 2022-09-15, under 510(k) number K221553.

Who is the listed applicant for Diamond Air+ (UI04A, UI04B, UI04C)?

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

What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C)?

The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C) is OHT.

其他以 Ulike 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。

K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)K213558IPL 髮毛去除器

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。

K261977布蘭恩光環9 (6042)Cyden Limited K262524藍寶石冷光脫毛儀器（Ice 2.0、Ice 2.1、Ice 2.2、Ice 2.0B、Ice 2.1B、Ice 2.2B）ONE BEAUTY Technology Co., Ltd.K261705除毛設備（R3C16-G Pro, R3C16-V Pro）Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325冰冷光療脫毛設備 (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL 髮毛去除器（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冰冷光療脫毛設備 (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

官方來源

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