Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242288
    Device Name
    Advanced Cryo Wart Remover
    Manufacturer
    Medical Brands Laboratories B.V.
    Date Cleared
    2025-01-21

    (172 days)

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

    Medical Brands Laboratories B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Advanced Cryo Wart Remover is designed as an over-the-counter (OTC) self-care device indicated for adults and children from the age of four years and older for the treatment of common and plantar warts.
    Device Description
    The Advanced Cryo Wart Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common and plantar warts. The device includes: - A 15 mL / 0.51 oz pressurized aerosol canister containing a freezing agent (1,1-Difluoroethane, Propane, and Isopentane). - A metal tip that applies the cryogen directly to the wart - Detailed instructions, including illustrated descriptions. To activate the product, the lay user must, while holding the device facing downward, press the side buttons firmly five times in a row. Apply the cold metal tip for 20 seconds on warts located on the hands, tops of feet, and toes. Apply for 40 seconds on plantar warts in areas with thicker or calloused skin. The device is non-sterile, reusable, and intended for home use by laypersons. No special training or sterilization is required for operation.
    Ask a Question

    Page 1 of 1