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510(k) Data Aggregation

    K Number
    K163079
    Device Name
    HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System
    Manufacturer
    HealthLight, LLC
    Date Cleared
    2017-06-13

    (222 days)

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

    HealthLight, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for the relaxation of muscle spasms, temporary relief of minor muscle and joint aches, pain and stiffness, temporarily relief of minor pain and stiffness associated with arthritis, and to temporarily increase local blood circulation. The HealthLight Footbed Model HL-FB is specifically indicated for treatment of the feet and lower legs.
    Device Description
    Not Found
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