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510(k) Data Aggregation

    K Number
    K140314
    Device Name
    WARTIE WART REMOVER
    Manufacturer
    YONMEDICAL BV
    Date Cleared
    2014-06-12

    (122 days)

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

    YONMEDICAL BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Wartie® Wart Remover is intended for over-the-counter treatment of common warts and plantar warts to be used in adults and children 4 years of age and older. Wartie® Wart Remover is indicated for the over-the-counter treatment of common warts for patients aged 4 years and older.
    Device Description
    The Wartie® Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home. Wartie® Wart Remover consists of: - A pressurized canister filled with 50ml of the compressed liquid gas dimethy) ether. - A custom application unit used to administer the cold delivered by the cryogen to the wart. - Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations. Wartie® Wart Remover technology involves freezing a wart (common and/or platar) using a very cold releasing liquid gas (cryogen) into a patented-pending applicator which, in turn become very cold and is able to freeze the skin. The freezing of the skin causes damage to the cells housing and protecting the wart. The latter either develops a blister underneath and falls off, or the damaged skin cells are discarded by the body, thereby also effectively removing the wart and the virus. Wartie® Wart Remover contains the following materials: Cap: PP Cone: POM Nose Piece: Bronze coated with Nickel Ring: POM Can: Aluminum
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