BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    TRANBERG Thermoguide Therapy System

    K Number: K214125 · Decision Sep 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    6
    Review Days
    266

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TRANBERG Thermoguide Therapy System
    K Number
    K214125
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Laserthermia Systems, AB
    Date Received
    December 30, 2021
    Decision Date
    September 22, 2022
    Product Code
    ONO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ONO Neurosurgical Laser With Mr Thermography

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ONO), ordered by most recent decision date.

    NeuroBlate System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

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

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Visualase V2 MRI-guided Laser Ablation System (9736422)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Monteris Medical NeuroBlate System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Visualase MRI-Guided Laser Ablation System (SW 3.4)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Clinical Laserthermia Systems, AB

    K Number Device Name
    K251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
    K201466 Tranberg CLS Laser Applicator
    K163103 Tranberg CLS Diffusor Laser Fiber
    K151569 Tranberg CLS Laser Fiber
    K142216 Tranberg CLS Thermal Therapy System