BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE

    K Number: K072048 · Decision Nov 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    3
    Review Days
    114

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    Basic Information

    Device Name
    LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE
    K Number
    K072048
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lynton Lasers Limited
    Date Received
    July 25, 2007
    Decision Date
    November 16, 2007
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Lynton Lasers Limited

    K Number Device Name
    K063427 LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM
    K062871 LUMACARE LC-122M NON-COHERENT LIGHT SOURCE