PICOPLUS 激光系統
K 號：K173700 · 2018-06-19
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器材摘要
PICOPLUS Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2018-06-19 under 510(k) number K173700. 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 PICOPLUS Laser System?
PICOPLUS Laser System is a medical device that received FDA 510(k) clearance on 2018-06-19. The listed applicant is Lutronic Corporation. The 510(k) number is K173700.
When did PICOPLUS Laser System receive FDA 510(k) clearance?
PICOPLUS Laser System received FDA 510(k) clearance on 2018-06-19, under 510(k) number K173700.
Who is the listed applicant for PICOPLUS Laser System?
The FDA 510(k) record lists Lutronic Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PICOPLUS Laser System?
The FDA product code for PICOPLUS Laser System is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 Lutronic 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
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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