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510(k) Data Aggregation

    K Number
    K964074
    Device Name
    DIOLITE 532
    Manufacturer
    IRIDERM DIV.
    Date Cleared
    1997-04-01

    (172 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K954905,K951034,K883541,K903883
    Why did this record match?
    Reference Devices :

    K954905, K951034, K883541, K903883

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DioLite™ 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.

    Device Description

    The DioLite 532 is a semiconductor-based dermatology laser system which delivers 532 nm laser light. The system delivers up to 3 Watts of power, in pulses of 1 to 100 milliseconds duration, at repetition rates up to 15 Hz, into treatment spots of 200 to 1400 microns diameter.

    AI/ML Overview

    This 510(k) summary for the IRIDEX Corporation DioLite™ 532 does not contain information regarding objective acceptance criteria or a study designed to prove the device meets such criteria.

    The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device's technical specifications and compares them to other legally marketed laser devices.

    Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details for an acceptance criteria study. This information is not present in the provided text.

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