BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    CLINICAL LASERTHERMIA SYSTEMS AB

    Reg #: 3012452798 · FEI: 3012452798 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    4
    Classifications
    5

    Registration Details

    Registration Name
    CLINICAL LASERTHERMIA SYSTEMS AB
    Registration Number
    3012452798
    FEI Number
    3012452798
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Scheelevagen 2
    City
    Lund Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K151569

    Owner / Operator

    Firm Name
    Clinical Laserthermia Systems AB
    Operator Number
    10050452
    Address
    Scheelevagen 2
    City
    Lund
    State
    Skane
    Postal Code
    22381
    Country
    SE
    Correspondent
    Lars-Erik Eriksson

    US Agent

    Business Name
    OMEDtech
    Contact Name
    David Makanani
    Address
    8501 Lullwater Dr., #1208
    City
    Dallas
    State
    TX
    ZIP
    75238
    Country
    US
    Email
    [email protected]
    Phone
    405 8260713

    Products

    Device Name Product Code
    Cannula, Surgical, General & Plastic Surgery GEA
    Trocar DRC
    Powered Laser Surgical Instrument GEX
    Neurosurgical Laser With Mr Thermography ONO
    Stylet, Surgical, General & Plastic Surgery GAH

    Proprietary Names

    MR Cannula Tranberg CLS Introducer/Trocar MRI Compatible Tranberg CLS Laser Fiber Tranberg CLS Thermal Therapy System TRANBERG Thermoguide Therapy System Tranberg CLS Diffusor Laser Fiber Tranberg CLS Laser Applicator MR Stylet

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device