LED光罩（A093）
K 號：K250880 · 2025-06-20
廣告
決定日期2025-06-20
產品代碼OHS
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
LED LIGHT MASK (A093) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Guangyu Weilai Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K250880. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LED LIGHT MASK (A093)?
LED LIGHT MASK (A093) is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Foshan Guangyu Weilai Medical Equipment Co., Ltd.. The 510(k) number is K250880.
When did LED LIGHT MASK (A093) receive FDA 510(k) clearance?
LED LIGHT MASK (A093) received FDA 510(k) clearance on 2025-06-20, under 510(k) number K250880.
Who is the listed applicant for LED LIGHT MASK (A093)?
The FDA 510(k) record lists Foshan Guangyu Weilai Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LED LIGHT MASK (A093)?
The FDA product code for LED LIGHT MASK (A093) is OHS.
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。
相關器械（代碼：OHS）
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。
K260767臉部美顏設備（臉部面膜LED美顏設備 A-901；臉部LED & EMS美顏設備 A-902；臉部面膜LED & EMS美顏設備 A-907）Kam Yuen Plastic Products , Ltd.K261602眼復原專家 (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光療面膜（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.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）Shenzhen Qianyu Technology Co., Ltd.K261496LED光療面膜（PE748、PE749、PE756）Duplex International Trading LimitedK261482LightStim 經皮光療機（1984年）；LightStim 痤瘡光療機（2038年）Led Intellectual Properties, LLC
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