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510(k) Data Aggregation

    K Number
    K240226
    Device Name
    Pixie Skin Tag
    Manufacturer
    Oystershell NV
    Date Cleared
    2024-10-18

    (266 days)

    Product Code
    ORE, GEH
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oystershell NV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pixie® Skin Tag is a cryogenic device for home use intended to treat skin tags in persons over the age of 21.
    Device Description
    Pixie Skin Taq is a pen-like cryogenic device that utilizes pressurized nitrous oxide (NoO, liquefied) to destroy skin tag tissue. The N2O is released into a single-use, disposable applicator, cooling the applicator as the result of rapid evaporation. The cooled applicator is briefly contacted with the skin tag while the surrounding tissue is protected by a disposable thermally insulating adhesive bandage. Each Pixie Skin Tag device is supplied in a carton with instructions for use and replacement applicator tips and insulating adhesive bandages.
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