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510(k) Data Aggregation

    K Number
    K161296
    Device Name
    Cool Renewal
    Manufacturer
    COOL RENEWAL, LLC
    Date Cleared
    2016-07-06

    (58 days)

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

    COOL RENEWAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane 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 pyogenic granuloma.
    Device Description
    Cool Renewal® is used in the practice of dermatology in the treatment of benign skin lesions using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a standard cryogen composition profile to freeze common skin lesions. The main device component is the aerosol canister containing cryogen spray. The device is used with non-sterile, single-patient applicators which are disposed after use. The applicators are available in Foam Tipped Applicators, Foam Tipped Skin Tag Tweezers, and Plastic Isolation Funnels. The device is provided in a kit containing the canisters, extender tubes, assorted applicators, Instructions for Use, Patient Instruction Tear Pad, and Applicator Practice Pad.
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