Préime DermaFacial (微T)
K 號：K243072 · 2025-04-01
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器材摘要
Préime DermaFacial (MicroT) 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 2025-04-01 under 510(k) number K243072. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Préime DermaFacial (MicroT)?
Préime DermaFacial (MicroT) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243072.
When did Préime DermaFacial (MicroT) receive FDA 510(k) clearance?
Préime DermaFacial (MicroT) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K243072.
Who is the listed applicant for Préime DermaFacial (MicroT)?
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 (MicroT)?
The FDA product code for Préime DermaFacial (MicroT) is NFO.
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：NFO）
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
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