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

    Tranberg CLS Diffusor Laser Fiber

    K Number: K163103 · Decision Mar 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    6
    Review Days
    136

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    Basic Information

    Device Name
    Tranberg CLS Diffusor Laser Fiber
    K Number
    K163103
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clinical Laserthermia Systems, AB
    Date Received
    November 7, 2016
    Decision Date
    March 23, 2017
    Product Code
    GEX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEX Powered Laser Surgical Instrument

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    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)
    K214125 TRANBERG Thermoguide Therapy System
    K201466 Tranberg CLS Laser Applicator
    K151569 Tranberg CLS Laser Fiber
    K142216 Tranberg CLS Thermal Therapy System