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510(k) Data Aggregation

    K Number
    K171398
    Device Name
    Dermal Cooling System
    Manufacturer
    R2 Dermatology ,Inc
    Date Cleared
    2017-07-06

    (55 days)

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

    R2 Dermatology ,Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.
    Device Description
    The Dermal Cooling System is a cryosurgical device used to cool the skin, without the use of cryogenic gases or liquids, for the removal of benign skin lesions. Surface contact cooling is achieved using a thermoelectric cooler (TEC), with an integrated aluminum plate, to lower the temperature of the skin. It is intended for use in a healthcare facility such as a clinic or doctor's office. The Dermal Cooling System is comprised of the following components: - . control unit – houses user interface display, the system controller, and the power converters - . chiller – provides circulating coolant to the handpiece to remove heat from the TEC - . handpiece - contains the TEC, temperature sensors, the aluminum cooling plate, and user interface elements - . isolation transformer – isolates system from AC mains power - . cart – houses the isolation transformer, chiller, and control unit
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