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FDA 510(k)

二极管激光系统（LaserPro D 980）；二极管激光系统（LaserPro D 810）；二极管激光系统（Aurolance 980）；二极管激光系统（Aurolance 810）；二极管激光系统（Aurolance AM）

K号: K243141 · 2024-12-26

申请人Jiangxi Medex Technology Co., Ltd.
决定日期2024-12-26
产品代码GEX
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Medex Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K243141. 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.

常见问题

What is the Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)?

Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Jiangxi Medex Technology Co., Ltd.. The 510(k) number is K243141.

When did Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) receive FDA 510(k) clearance?

Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) received FDA 510(k) clearance on 2024-12-26, under 510(k) number K243141.

Who is the listed applicant for Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)?

The FDA 510(k) record lists Jiangxi Medex Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)?

The FDA product code for Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) is GEX. This falls under the Gastroenterology category.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Jiangxi Medex Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K243121SLT Select 纤维输送系统及接触尖端（型号：SSRH 8-SMA；TCRH 7-SMA；FEF 2.2-SMA；CFE 0.6-SMA；SSRH 8Z-SMA；SSRH 4-SMA；SSRH 6-SMA；SSRH 9-SMA；SSRH 10-SMA；SSRH 11-SMA；SSRH 7L-SMA；TCRH 7Z-SMA；FEF 1.8-SMA；CFE 0.55-SMA；CFE 0.36-SMA；LAL 550-SMA；LAL 550Z-SMA；LAL 365-SMA；LAL 365Z-SMA；ER2；ERP2；GR2；GRP2；ER4；ERP4；GR4；GRP4；ER6；ERP6；GR6；GRP6；ER8；ERP8；GR8；GRP8；ER10；ERP10；GR10；GRP10；ER12；ERP12；GR12；GRP12；MD2.5；MD3.5；HP1.0；MTP1.5；MTP3.5；MTRG1.5；

相关器械（代码：GEX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254199PicoreMax（PicoreMax）BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI 系统Lumenis Be, Ltd.K261047牙科二极管激光设备（激光笔）Guilin Kevin Peter Technology Co., Ltd.K261817二极管激光治疗系统（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治疗设备（QLXY-01）Beijing Nubway S&T Co., Ltd.

官方来源

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