FDA 510(k)

手持式IPL設備（JOVS 髮毛去除設備）

K 號：K220645 · 2022-04-27

決定日期2022-04-27

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

Hand-held IPL device (JOVS Hair Removal Device) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220645. 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 Hand-held IPL device (JOVS Hair Removal Device)?

Hand-held IPL device (JOVS Hair Removal Device) is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. The 510(k) number is K220645.

When did Hand-held IPL device (JOVS Hair Removal Device) receive FDA 510(k) clearance?

Hand-held IPL device (JOVS Hair Removal Device) received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220645.

Who is the listed applicant for Hand-held IPL device (JOVS Hair Removal Device)?

FDA 510(k) 記錄將深圳千宇科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Hand-held IPL device (JOVS Hair Removal Device)?

The FDA product code for Hand-held IPL device (JOVS Hair Removal Device) is OHT.

其他以 Shenzhen Qianyu 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。

K261851LED光療治療面膜（JML1，JML1+JML2）；LED光療治療面膜（JML3，JML3+JML4）；LED光療治療面膜（JML5，JML5+JML7）；LED光療治療面膜（JML6，JML6+JML8）；LED光療治療面膜（JML9，JML9+JML10）K250227JOVS 電動刺激美容設備（JE2）K244020皺紋治療設備（JM1，JM2B）K240360皺紋治療設備（JM2）K231800IPL 髮毛去除器，型號：JP1、JR3、JR8、JR9 K214113手持式IPL設備（JOVS石墨烯除毛設備）

查看所有 7 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。