超清晰雷射系統（N/A）
K 號：K233803 · 2024-05-08
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器材摘要
UltraClear Laser System (N/A) is the device name listed in this FDA 510(k) record. The listed applicant is Acclaro Corporation. It received FDA 510(k) clearance on 2024-05-08 under 510(k) number K233803. 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 UltraClear Laser System (N/A)?
UltraClear Laser System (N/A) is a medical device that received FDA 510(k) clearance on 2024-05-08. The listed applicant is Acclaro Corporation. The 510(k) number is K233803.
When did UltraClear Laser System (N/A) receive FDA 510(k) clearance?
UltraClear Laser System (N/A) received FDA 510(k) clearance on 2024-05-08, under 510(k) number K233803.
Who is the listed applicant for UltraClear Laser System (N/A)?
The FDA 510(k) record lists Acclaro Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltraClear Laser System (N/A)?
The FDA product code for UltraClear Laser System (N/A) 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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