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510(k) Data Aggregation

    K Number
    K203481
    Device Name
    CryoVIVE
    Manufacturer
    Recens Medical Inc.
    Date Cleared
    2021-05-13

    (167 days)

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

    Recens Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CryoVIVE(Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures - Molluscum Contagiosum - Skin Tags - Actinic Keratosis - Lentigo - Verruca Plana - Verruca Vulgaris - Verruca Lesions - Genital Lesions - Seborrheic Keratosis The CryoVIVE(Cooling mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).
    Device Description
    The CryoVIVE is a handheld device that delivers rapid, precise and controlled cooling temperature to the skin tissue with the use of CO2 gas cartridge. The CryoVIVE consists of main system, nozzles(Cooling nozzle and Freezing nozzle), Guide tip, filter, and CO2 cartridge. The CryoVIVE offers two treatment modes, which can be changed by using different nozzles. In cooling mode, the main device produces controlled cooling based on thermoelectric cooling, which control the temperature (2-4°C) of targeted area. In freezing mode, the main device delivers the CO2 gas of extreme cold temperature (-79°C) , which causes the surgical destruction of target tissue. The CryoVIVE displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD screen. Also, if the temperature below -1°C lasts for more than 1 second, the front LED blinks in blue with a beep sound.
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