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510(k) Data Aggregation

    K Number
    K060653
    Device Name
    THERMACLEAR
    Manufacturer
    DERMACARE, INC.
    Date Cleared
    2006-10-24

    (225 days)

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

    DERMACARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ThermaClear is indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
    Device Description
    ThermaClear™ is a portable hand-held device that uses a short thermal pulse to treat mild to moderate inflammatory acne. The treatment tip is comprised of biocompatible material and delivers a short duration thermal pulse that heats the area being treated. The device is powered by two AA alkaline batteries.
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