ESPADA 痤瘡清潔藍光筆
K 號：K162450 · 2016-11-30
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器材摘要
ESPADA Acne-Clearing Blue Light Pen is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K162450. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ESPADA Acne-Clearing Blue Light Pen?
ESPADA Acne-Clearing Blue Light Pen is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Foreo, Inc.. The 510(k) number is K162450.
When did ESPADA Acne-Clearing Blue Light Pen receive FDA 510(k) clearance?
ESPADA Acne-Clearing Blue Light Pen received FDA 510(k) clearance on 2016-11-30, under 510(k) number K162450.
Who is the listed applicant for ESPADA Acne-Clearing Blue Light Pen?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ESPADA Acne-Clearing Blue Light Pen?
The FDA product code for ESPADA Acne-Clearing Blue Light Pen is OLP.
相關臨床試驗
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其他以 Foreo, Inc. 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：OLP）
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。
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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。
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