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510(k) Data Aggregation

    K Number
    K970017
    Device Name
    NIDEK CYBERSCAN
    Manufacturer
    NIDEK, INC.
    Date Cleared
    1997-03-18

    (75 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K955734
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a Summary of Safety and Effectiveness for the CyberScan Device System (K970017). It states that the device is substantially equivalent to a predicate device (ParaScan Dosimeter Device, K955734).

    However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the given input. The document focuses on regulatory classification, indications for use, and a comparison to a predicate device for substantial equivalence, rather than detailing performance studies and their results.

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