Fotona XPulse Pro 激光平台
K 號：K202991 · 2021-06-22
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器材摘要
Fotona XPulse Pro Laser Platform is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K202991. 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 Fotona XPulse Pro Laser Platform?
Fotona XPulse Pro Laser Platform is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is Fotona D.O.O.. The 510(k) number is K202991.
When did Fotona XPulse Pro Laser Platform receive FDA 510(k) clearance?
Fotona XPulse Pro Laser Platform received FDA 510(k) clearance on 2021-06-22, under 510(k) number K202991.
Who is the listed applicant for Fotona XPulse Pro Laser Platform?
FDA 510(k) 記錄將 Fotona D.O.O. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Fotona XPulse Pro Laser Platform?
The FDA product code for Fotona XPulse Pro Laser Platform is GEX. This falls under the Gastroenterology category.
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 Fotona D.O.O. 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
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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