光融合LED系統
K 號：K162556 · 2017-03-24
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器材摘要
LIGHTFUSION LED SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vitage Led, Ltd.. It received FDA 510(k) clearance on 2017-03-24 under 510(k) number K162556. 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 LIGHTFUSION LED SYSTEM?
LIGHTFUSION LED SYSTEM is a medical device that received FDA 510(k) clearance on 2017-03-24. The listed applicant is Vitage Led, Ltd.. The 510(k) number is K162556.
When did LIGHTFUSION LED SYSTEM receive FDA 510(k) clearance?
LIGHTFUSION LED SYSTEM received FDA 510(k) clearance on 2017-03-24, under 510(k) number K162556.
Who is the listed applicant for LIGHTFUSION LED SYSTEM?
The FDA 510(k) record lists Vitage Led, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LIGHTFUSION LED SYSTEM?
The FDA product code for LIGHTFUSION LED SYSTEM is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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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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