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510(k) Data Aggregation

    K Number
    K014253
    Device Name
    DERMACHILLER 4
    Manufacturer
    PARADIGM TREX, LLC
    Date Cleared
    2002-03-26

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM TREX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DermaChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
    Device Description
    The DermaChiller consists of a source of a refrigerant fluid controlled by an electronically operated solenoid delivery valve. The refrigerant fluid is sprayed in a controlled fashion onto a sapphire window, which is cooled and applied to skin.
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