Heager醫療雷射系列（Sabrina/Adolf）
K 號：K250261 · 2025-08-26
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器材摘要
Heager Medical Laser Family (Sabrina/Adolf) is the device name listed in this FDA 510(k) record. The listed applicant is Heager GmbH. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K250261. 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 Heager Medical Laser Family (Sabrina/Adolf)?
Heager Medical Laser Family (Sabrina/Adolf) is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Heager GmbH. The 510(k) number is K250261.
When did Heager Medical Laser Family (Sabrina/Adolf) receive FDA 510(k) clearance?
Heager Medical Laser Family (Sabrina/Adolf) received FDA 510(k) clearance on 2025-08-26, under 510(k) number K250261.
Who is the listed applicant for Heager Medical Laser Family (Sabrina/Adolf)?
The FDA 510(k) record lists Heager GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Heager Medical Laser Family (Sabrina/Adolf)?
The FDA product code for Heager Medical Laser Family (Sabrina/Adolf) 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。
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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