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510(k) Data Aggregation

    K Number
    K992083
    Device Name
    SCATTERFREE LATERAL EMITTING FIBER
    Manufacturer
    LASER PERIPHERALS LLC.
    Date Cleared
    1999-07-12

    (21 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SCATTERFREE LATERAL EMITTING FIBER

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

    The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.

    Device Description

    ScatterFree™ Lateral Emitting Fiber

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the ScatterFree™ Lateral Emitting Fiber. It describes the device's intended use and states that it has been found substantially equivalent to predicate devices. However, this document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about ground truth, sample sizes, or expert adjudication.

    Therefore, I cannot provide the requested information from the given input. The document is administrative in nature, confirming regulatory clearance, rather than a scientific study report.

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