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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
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K984110,K001589,K990417
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARADIGM TREX, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets those criteria. The document is a 510(k) summary for DermaChiller 4, which outlines its intended use, classification, and substantial equivalence to other devices. It does not include details on clinical trials, effectiveness studies, or performance metrics against specific acceptance criteria.

    Therefore, I cannot fulfill your request for the table and study details.

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