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510(k) Data Aggregation

    K Number
    K212189
    Device Name
    FibroLux
    Manufacturer
    Multi Radiance Medical
    Date Cleared
    2022-09-02

    (416 days)

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

    Multi Radiance Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FibroLux is indicated for adjunctive use in the temporary relief of pain associated with fibromyalgia.
    Device Description
    Not Found
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    K Number
    K171354
    Device Name
    MR4 Laser
    Manufacturer
    Multi Radiance Medical
    Date Cleared
    2018-01-13

    (249 days)

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

    Multi Radiance Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MR4 Laser is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
    Device Description
    Not Found
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