BEUDAMED
    FDA Registration Active 🇸🇪 Sweden

    Tranberg CLS Laser Applicator

    Reg #: 3012452798 · FEI: 3012452798 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLINICAL LASERTHERMIA SYSTEMS AB
    Registration Number
    3012452798
    FEI Number
    3012452798
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Scheelevagen 2
    City
    Lund Skane
    Country
    SE

    Regulatory Submissions

    510(k) Number
    K201466

    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, LLC
    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
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Tranberg CLS Laser Applicator

    Establishment Types

    Manufacture Medical Device