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510(k) Data Aggregation

    K Number
    K253683

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-02-20

    (91 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FAQ™ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light

    Device Description

    Not Found

    AI/ML Overview

    N/A

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