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510(k) Data Aggregation

    K Number
    K201366
    Device Name
    Forwarts
    Date Cleared
    2021-01-21

    (244 days)

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

    Pronova Laboratories BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Forwarts® is indicated for the treatment of warts on hands (common warts) and feet (plantar warts).
    Device Description
    Forwarts® is a wart removal device that works by the principle of cryotherapy and is intended for the treatment of common and plantar warts. It delivers a precise cryogenic spray directly onto a wart or verruca which causes them to freeze and fall off the skin in approximately 10-14 days. The device consists of a pressurized aerosol can containing 35 ml dimethyl ether (DME). The aerosol can is held in a polypropylene shell (front and back). The front shell contains a distance holder for a safe and regulated application and a visor to point and limit the spray pattern. The translucent back shell contains a ridge for safe handling. The valve system will be extended by an actuator to point and minimize the spray pattern. Forwarts® is supplied with ten (10) protection patches per device to be placed around the wart prior to treatment to help prevent damage of healthy skin. Forwarts® is supplied non-sterile and not intended to be sterilized by the end user. The Forwarts® nozzle should be cleaned after each use with rubbing alcohol (70%).
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