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510(k) Data Aggregation

    K Number
    K992050
    Device Name
    LUMENON XENON LIGHT SOURCE
    Manufacturer
    WALTER LORENZ SURGICAL, INC.
    Date Cleared
    1999-09-14

    (89 days)

    Product Code
    GCT
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LUMENON XENON LIGHT SOURCE

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

    The Lumenon™ Xenon Light Source is intended to supply adjustable high intensity illumination for accessories such as headlights and endoscopes.

    Device Description

    The Lumenon™ Xenon Light Source is a fiberoptic illuminator for supplying high intensity illumination for accessories such as headlights and endoscopes. The device has a universal turret with four (4) receptacles to accept various light cables. It features a quick-change lamp module and two (2) lamp life indicators. The device incorporates a graduated shutter to attenuate the intensity of the light output, adjustable from 0 to 100 percent. The intensity control is adjusted by turning the attenuater knob located on the front panel The Lumenon™ Light Source utilizes a Plano Convex Lens for focusing light down to the diameter of the fiber optic cable. The 5600°K, light is produced by a Xenon Ceramic Short Arc Lamp. The visible output is 515 X 10(3) Candelas. The equivalent visible output in terms of Lux is 47,862 Lux. ORC coats the glass window of the xenon lamp in order to reduce UV output. The IR is reduced by a glass filter with an IR coating which blocks IR transmissions. UV output is 2.6 watts.

    AI/ML Overview

    The provided text describes a medical device, the Lumenon™ Xenon Light Source, and its regulatory clearance (510(k) K992050) by the FDA. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria as typically outlined in an AI/software medical device submission.

    The document provided is a summary of safety and effectiveness for a conventional hardware medical device (a light source), not an AI/software-based device. Therefore, the requested information about acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, or training sets is not present in this type of submission.

    The "Summary of Safety and Effectiveness" for this device focuses on:

    • Intended Use: To supply adjustable high-intensity illumination for accessories such as headlights and endoscopes.
    • Device Description: Specifics about its components, light output, and safety features (e.g., UV/IR reduction).
    • Potential Risks: Hazards associated with its use (flammable gases, high temperatures, radiation, electrical safety).
    • Substantial Equivalence: Comparison to existing legally marketed predicate devices (Welch Allyn Xenon 300 Light Source, Xenon Light Source Model LS 6035). The argument for clearance is that its operational principles and technological characteristics are substantially equivalent, and any differences are minor and do not raise new safety or effectiveness issues.

    Therefore, I cannot populate the table or answer the specific questions because the provided text does not contain the information requested for AI/software device evaluation.

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