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510(k) Data Aggregation

    K Number
    K142722
    Device Name
    3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
    Manufacturer
    Date Cleared
    2015-01-13

    (112 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Livetec GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laser Pen is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffhess, arthritis pain, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
    Device Description
    Not Found
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    K Number
    K142215
    Device Name
    Power Twin21-50/Power Twin21-100
    Manufacturer
    Date Cleared
    2014-11-07

    (87 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIVETEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Power Twin 21 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
    Device Description
    Not Found
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    K Number
    K131797
    Device Name
    3B LASER NEEDLE
    Manufacturer
    Date Cleared
    2013-10-10

    (114 days)

    Product Code
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIVETEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The 3B Laser Needle is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
    Device Description
    Not Found
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