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510(k) Data Aggregation

    K Number
    K022610
    Device Name
    CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160
    Manufacturer
    CLARUS MEDICAL, LLC.
    Date Cleared
    2002-11-05

    (91 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K922881,K011207,K973172,K992083,K972272
    Why did this record match?
    Device Name :

    CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160

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

    The Clarus Model 1150 Straight Firing Laser Fiber may be used both intraoperatively and percutaneously through regulatory cleared delivery systems.

    The Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

    Device Description

    Model 1150 Clarus Straight Firing Laser Fiber

    AI/ML Overview

    The provided text is a 510(k) summary for the "Model 1150 Clarus Straight Firing Laser Fiber." It details general information, predicate devices, intended use, and the FDA's regulatory response. However, it does not include any information about detailed acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and study summary. The document is solely a regulatory submission and approval notification, not a performance study report.

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