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FDA 510(k)

TRANBERG Thermoguide Therapy System

K-Number: K214125 · 2022-09-22

ApplicantClinical Laserthermia Systems, AB
Decision Date2022-09-22
Product CodeONO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRANBERG Thermoguide Therapy System is a medical device manufactured by Clinical Laserthermia Systems, AB. It received FDA 510(k) clearance on 2022-09-22 under approval number K214125. 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 TRANBERG Thermoguide Therapy System?

TRANBERG Thermoguide Therapy System is a medical device that received FDA 510(k) clearance on 2022-09-22. It is manufactured by Clinical Laserthermia Systems, AB. The 510(k) number is K214125.

When was TRANBERG Thermoguide Therapy System approved by the FDA?

TRANBERG Thermoguide Therapy System received FDA 510(k) clearance on 2022-09-22, under approval number K214125.

What company makes TRANBERG Thermoguide Therapy System?

TRANBERG Thermoguide Therapy System is manufactured by Clinical Laserthermia Systems, AB.

What is the FDA product code for TRANBERG Thermoguide Therapy System?

The FDA product code for TRANBERG Thermoguide Therapy System is ONO.

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025)

Other Devices by Clinical Laserthermia Systems, AB

K151569Tranberg CLS Laser Fiber K163103Tranberg CLS Diffusor Laser Fiber K201466Tranberg CLS Laser Applicator K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

Related Devices (Code: ONO)

K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. K240877Monteris Medical NeuroBlate SystemMonteris Medical, K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)Clinical Laserthermia Systems, AB 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

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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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