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FDA 510(k)

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

K-Number: K251298 · 2025-09-04

ApplicantClinical Laserthermia Systems, AB
Decision Date2025-09-04
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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 manufactured by Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2025-09-04 under approval number K251298. The device is classified under product code ONO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Clinical Laserthermia Systems, AB. The 510(k) number is K251298.

When was Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) approved by the FDA?

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 approval number K251298.

What company makes 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 manufactured by Clinical Laserthermia Systems, AB.

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.

Related Clinical Trials

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Other Devices by Clinical Laserthermia Systems, AB

K151569Tranberg CLS Laser Fiber K163103Tranberg CLS Diffusor Laser Fiber K201466Tranberg CLS Laser Applicator K214125TRANBERG Thermoguide Therapy System

Related Devices (Code: ONO)

K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. K240877Monteris Medical NeuroBlate SystemMonteris Medical, K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation K260976NeuroBlate SystemMonteris Medical K253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)Medtronic Navigation, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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