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510(k) Data Aggregation

    K Number
    K111341
    Device Name
    CLEANE / CLEANE POP
    Manufacturer
    MEDICON CO., LTD.
    Date Cleared
    2012-02-29

    (293 days)

    Product Code
    OZC
    Regulation Number
    890.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICON CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CLEANE and the CLEANE POP are indicated for the treatment of individual acne pimples in persons with mild to moderate inflammatory acne.
    Device Description
    The CLEANE and the CLEANE POP are potable had-held devices that produce accurately controlled low level sustained heat for use in treating mild to moderate acne. The devices are designed to treat individual acne blemishes for 2 1/2 minutes at a preset temperature. The treatment tip is made from a biocompatible material and delivers the specific low-level heat to the individual acne blemish.
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