二極雷射除毛系統
K 號：K241860 · 2024-09-25
廣告
器材摘要
Diode Laser Hair Removal System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Winkonlaser Technology Limited. It received FDA 510(k) clearance on 2024-09-25 under 510(k) number K241860. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the Diode Laser Hair Removal System?
Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2024-09-25. The listed applicant is Beijing Winkonlaser Technology Limited. The 510(k) number is K241860.
When did Diode Laser Hair Removal System receive FDA 510(k) clearance?
Diode Laser Hair Removal System received FDA 510(k) clearance on 2024-09-25, under 510(k) number K241860.
Who is the listed applicant for Diode Laser Hair Removal System?
FDA 510(k) 記錄將北京威科納激光技術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 Diode Laser Hair Removal System?
The FDA product code for Diode Laser Hair Removal System is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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。
其他以 Beijing Winkonlaser Technology Limited 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：GEX）
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。
K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro 系列Fotona D.O.O.K241973SmartIPL_NI 系統Lumenis Be, Ltd.K261047牙科二極雷射設備（雷射筆）Guilin Kevin Peter Technology Co., Ltd.K261817二極雷射治療系統（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治療設備（QLXY-01）Beijing Nubway S&T 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。
廣告