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510(k) Data Aggregation

    K Number
    K102006
    Device Name
    CRYOMEGA
    Manufacturer
    STC CONSULTING LLC
    Date Cleared
    2010-10-06

    (82 days)

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

    STC CONSULTING LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated. -Genital Lesions -Molluscum Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana -Actinic Keratosis -Lentigo
    Device Description
    The CryOmega device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device contains a 16g cartridge of nitrous oxide that is dispensed once the device is activated. Physicians or medical professionals can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C). Unlike the predicate device, the CryOmega is designed to be self contained and disposable after all of the liquefied gas has been dispensed.
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