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510(k) Data Aggregation

    K Number
    K130866
    Device Name
    BIOLIGHT BIODYNAM
    Manufacturer
    BIOLIGHT AB
    Date Cleared
    2013-10-25

    (211 days)

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

    BIOLIGHT AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.
    Device Description
    The Biolight Biodynam consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.
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