Préime 肌膚美顏膠原蛋白+
K 號：K243055 · 2025-04-15
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器材摘要
Préime DermaFacial Collagen+ is the device name listed in this FDA 510(k) record. The listed applicant is EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-15 under 510(k) number K243055. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Préime DermaFacial Collagen+?
Préime DermaFacial Collagen+ is a medical device that received FDA 510(k) clearance on 2025-04-15. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243055.
When did Préime DermaFacial Collagen+ receive FDA 510(k) clearance?
Préime DermaFacial Collagen+ received FDA 510(k) clearance on 2025-04-15, under 510(k) number K243055.
Who is the listed applicant for Préime DermaFacial Collagen+?
The FDA 510(k) record lists EMA Aesthetics , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Préime DermaFacial Collagen+?
The FDA product code for Préime DermaFacial Collagen+ is PBX.
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 EMA Aesthetics , 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。
相關器械（代碼：PBX）
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。
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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