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FDA 510(k)

TRI-BEAM PRO, TRI-BEAM (Nd:YAG 激光單元)

K 號：K251464 · 2025-10-03

申請人Jeisys Medical Incorporated
決定日期2025-10-03
產品代碼GEX
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is the device name listed in this FDA 510(k) record. The listed applicant is Jeisys Medical Incorporated. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K251464. 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 TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Jeisys Medical Incorporated. The 510(k) number is K251464.

When did TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) receive FDA 510(k) clearance?

TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) received FDA 510(k) clearance on 2025-10-03, under 510(k) number K251464.

Who is the listed applicant for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

FDA 510(k) 記錄將 Jeisys Medical Incorporated 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)?

The FDA product code for TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) is GEX. This falls under the Gastroenterology category.

相關臨床試驗

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其他以 Jeisys Medical Incorporated 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。

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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

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