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510(k) Data Aggregation

    K Number
    K030810
    Device Name
    COOLAN 300
    Manufacturer
    COOLANALGESIA LTD.
    Date Cleared
    2004-05-05

    (419 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CoolAn 300 device is intended as a skin-cooling device used to minimize pain and thermal injury during laser and light-based dermatological treatments. Alternative uses include skin cooling as a local topical anesthetic for injections.

    Device Description

    CoolAn 300

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA, which confirms that a device (CoolAn 300) is substantially equivalent to a legally marketed predicate device.

    While it mentions "indications for use," it does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about a study, including sample sizes, data provenance, expert qualifications, or adjudication methods.
    • Information on MRMC comparative effectiveness studies or standalone algorithm performance.
    • How ground truth was established for training or test sets.

    Essentially, this document is a regulatory approval, not a scientific study report.

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