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510(k) Data Aggregation

    K Number
    K172049
    Device Name
    CryoIQ DERM, CryoIQ PRO, CryoIQ EquiMED
    Manufacturer
    Date Cleared
    2017-08-30

    (55 days)

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

    Cry IQ AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CryoIQ Multi LINE are reusable devices intended to destroy tissue during surgical procedures by applying extreme cold.
    Device Description
    The CryoIQ devices consist of a unit body with a lever and an applicator (capillary tube, tip). A disposable cartridge filled with nitrous oxide (N₂O, laughing qas) will be attached to the unit body by slightly screwing into it. The cartridge has a build-in valve for safety storage and release of the gas. The CryoIQ designed to dispense a continuous stream of liquid nitrous oxide when actuated by pressing the lever. The device functions by means of heat evaporation upon phase transition where the nitrous oxide is applied to the treatment area by means of the applicator (capillary tube, tip) at a constant temperature of -89°C/-128°F (cold performance) followed by evaporation. Physicians or medical professionals can use the gas in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C/-128°F).
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