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510(k) Data Aggregation

    K Number
    K201740
    Device Name
    Hydrozid
    Manufacturer
    Date Cleared
    2021-07-07

    (377 days)

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

    MediLink A/S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Hydrozid (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
    Device Description
    Hydrozid® is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, singlepatient application templates which are disposed after use.
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