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510(k) Data Aggregation

    K Number
    K974468
    Device Name
    PHOTONIC STIMULATOR
    Manufacturer
    BALES SCIENTIFIC, INC.
    Date Cleared
    1998-06-22

    (208 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHOTONIC STIMULATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation, thereby providing safe, temporary relief of minor aches and pains where heat is indicated.

    Device Description

    The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Photonic Stimulator." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is solely an FDA clearance letter for marketing the device. Therefore, I cannot provide the requested information from this document.

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