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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 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.

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. 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.

Other records listing Clinical Laserthermia Systems, AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K214125TRANBERG Thermoguide Therapy SystemK201466Tranberg CLS Laser ApplicatorK163103Tranberg CLS Diffusor Laser FiberK151569Tranberg CLS Laser Fiber

Related Devices (Code: ONO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260976NeuroBlate SystemMonteris MedicalK253391Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)Medtronic Navigation, Inc.K250307Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic NavigationK240877Monteris Medical NeuroBlate SystemMonteris Medical,K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, ABK211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc.

Official Source

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

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