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510(k) Data Aggregation

    K Number
    K152203
    Device Name
    UTERMOHLEN CRYO PROFESSIONAL
    Date Cleared
    2015-11-06

    (92 days)

    Product Code
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    KONINKLIJKE (ROYAL) UTERMOHLEN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is indicated for the removal of the following skin lesions: - Verrucae plantaris - Verrucae Plana - Verrucae vulgaris - Mollescum contagiosum - Skin tags - = Actinic keratosis - Genital warts " - Lentigo - । Seborrhoeic Keratosis
    Device Description
    The product is a portable cryosurqery system which is prescription only intended for medical professionals. It is indicated for removal of skin lesions. The product is comprised of a dispenser (canister) containing a cryogen (cryoliquid) which freezes the lesion. It is packaged with a box of single-use foam-sticks (buds). The foam-stick is placed in the front of the dispenser into the opening under the applicator cap. The applicator button is pressed to dispel cryogen on the foamstick (bud). The foam-stick is applied to the skin lesion for the designated time to freeze the skin lesion.
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