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510(k) Data Aggregation

    K Number
    K021550
    Device Name
    LUMENIS SELECTA DUET
    Manufacturer
    Ellex Medical Pty. Ltd.
    Date Cleared
    2002-08-09

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K051944,K081704,K090774,K130933,K203130,K212630
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CAPSULOTOMY
    POSTERIOR IRIDOTOMY / IRIDECTOMY
    POSTERIOR MEMBRANECTOMY
    SELECTIVE LASER TRABELULOPLASTY (SLT)

    Device Description

    Not Found

    AI/ML Overview

    This document is a FDA 510(k) substantial equivalence determination letter for the Lumenis Selecta Duet. It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the stated indications for use, but it does not provide performance data, study design, or ground truth information.

    Therefore, I cannot extract the requested information from the provided text.

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