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FDA 510(k)

Visualase 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）

K号: K253391 · 2026-03-13

申请人Medtronic Navigation, Inc.
决定日期2026-03-13
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

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K253391. 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 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K253391.

When did Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) receive FDA 510(k) clearance?

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) received FDA 510(k) clearance on 2026-03-13, under 510(k) number K253391.

Who is the listed applicant for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

The FDA product code for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) 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Medtronic Navigation, Inc.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。

K253379Stealth AXiS颅部临床应用K253395Stealth AXiS™ ENT临床应用K253381Stealth AXiS™手术系统及Stealth AXiS™脊柱临床应用K251282StealthStation S8脊柱软件K242464Stealth® 脊柱夹具；ModuLeX® 股轴安装座K240465O-arm O2成像系统

查看所有 24 个设备 →

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 MedicalK251298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）Clinical Laserthermia Systems, ABK250307Visualase 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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