黃星
K 號：K261094 · 2026-04-29
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器材摘要
YellowStar is the device name listed in this FDA 510(k) record. The listed applicant is Asclepion Laser Technologies GmbH. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K261094. 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 YellowStar?
YellowStar is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is Asclepion Laser Technologies GmbH. The 510(k) number is K261094.
When did YellowStar receive FDA 510(k) clearance?
YellowStar received FDA 510(k) clearance on 2026-04-29, under 510(k) number K261094.
Who is the listed applicant for YellowStar?
The FDA 510(k) record lists Asclepion Laser Technologies GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for YellowStar?
The FDA product code for YellowStar is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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其他以 Asclepion Laser Technologies GmbH 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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