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510(k) Data Aggregation

    K Number
    K111937
    Device Name
    CLEARFLASH AC2100 COSMETIC SYSTEM
    Date Cleared
    2012-02-08

    (215 days)

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

    CLEARFLASH TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ClearFlash AC2100 Cosmetic System is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
    Device Description
    The ClearFlash AC2100 is a compact, handheld device that delivers a controlled pulse of thermal energy to the skin for treating dermatological disorders, specifically, mild to moderate inflammatory acne. An acne lesion is treated by applying the tip of the ClearFlash AC2100 device to the skin area and pressing a pulse activation button that releases a controlled amount of thermal energy into the skin. After the pulse is delivered to the skin the ClearFlash AC2100 device is removed from the acne lesion and the treatment is complete. The treated area on the skin can then be cleaned with an over-the-counter astringent. The ClearFlash AC2100 device is powered by a 9V battery.
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