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FDA 510(k)

移动激光单元（1001-N2）；Thermoguide 工作站（1100-N1）；激光应用器（4012-N5，4017-N2，4017-N4）；MR 引导器（4013-N6）

K号: K251298 · 2025-09-04

申请人Clinical Laserthermia Systems, AB
决定日期2025-09-04
产品代码ONO
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

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2025-09-04 under 510(k) number K251298. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is a medical device that received FDA 510(k) clearance on 2025-09-04. The listed applicant is Clinical Laserthermia Systems, AB. The 510(k) number is K251298.

When did Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) receive FDA 510(k) clearance?

Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) received FDA 510(k) clearance on 2025-09-04, under 510(k) number K251298.

Who is the listed applicant for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

The FDA 510(k) record lists Clinical Laserthermia Systems, AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)?

The FDA product code for Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) is ONO.

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Clinical Laserthermia Systems, AB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。

K214125TRANBERG 热导治疗系统K201466Tranberg CLS 激光治疗仪K163103Tranberg CLS 扩散激光光纤K151569Tranberg CLS 激光光纤

相关器械（代码：ONO）

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。

K262315NeuroBlate 系统Monteris MedicalK260976NeuroBlate 系统Monteris MedicalK253391Visualase 冷却激光治疗仪系统（9735559）；Visualase 冷却激光治疗仪系统（9735560）；Visualase 冷却激光治疗仪系统（9735561）Medtronic Navigation, Inc.K250307Visualase V2 MRI引导激光消融系统（9736422）Medtronic NavigationK240877Monteris Medical NeuroBlate 系统Monteris Medical,K214125TRANBERG 热导治疗系统Clinical Laserthermia Systems, AB

官方来源

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