GentleMax Pro Plus
K 號：K201111 · 2020-05-26
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器材摘要
GentleMax Pro Plus is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2020-05-26 under 510(k) number K201111. 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 GentleMax Pro Plus?
GentleMax Pro Plus is a medical device that received FDA 510(k) clearance on 2020-05-26. The listed applicant is Candela Corporation. The 510(k) number is K201111.
When did GentleMax Pro Plus receive FDA 510(k) clearance?
GentleMax Pro Plus received FDA 510(k) clearance on 2020-05-26, under 510(k) number K201111.
Who is the listed applicant for GentleMax Pro Plus?
The FDA 510(k) record lists Candela Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GentleMax Pro Plus?
The FDA product code for GentleMax Pro Plus is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 Candela Corporation 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。
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官方來源
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