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    K Number
    K220729
    Device Name
    The Luminance RED Acne Device
    Manufacturer
    Luminance Medical Ventures, Inc.
    Date Cleared
    2022-06-09

    (87 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Luminance Medical Ventures, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Luminance RED Acne Device is intended to enit energy in the spectrum, and is specifically indicated to treat mild to moderate acne.
    Device Description
    The Luminance RED Acne Device is a lightweight, handheld device that consists of a body handle and treatment head. The body handle contains 2 LEDs that emit visible blue light (415 nm +/- 10 nm) or visible red light (660 nm +/- 10 nm) through the treatment head to help reduce the appearance of mild to moderate acne. The body consists of a plastic shell which includes a button to turn the device on/off, a button for red visible light, a button for blue visible light, and a digital countdown timer. The Luminance RED Acne Device is powered by a lithium-ion battery.
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