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510(k) Data Aggregation

    K Number
    K983965
    Device Name
    CO2 LASER COUPLER
    Manufacturer
    LASER, INC.
    Date Cleared
    1998-12-22

    (46 days)

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

    The coupler interfaces at the distal knuckle of the CO2 Laser and either the operating laparoscope or second puncture tubes allowing direct delivery of the focused beam.

    Device Description

    CO2 Laser Coupler

    AI/ML Overview

    This is a 510(k) clearance letter from the FDA for a CO2 Laser Coupler. It indicates legal marketing of the device based on substantial equivalence to a predicate device. However, this document does not contain any information regarding specific acceptance criteria, device performance studies, or clinical trial data.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or detailed performance specification documents that would typically accompany a regulatory submission if performance data was required for the clearance.

    Therefore, for the provided input, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

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