Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K102167
    Device Name
    LO-50 LED LIGHT SOURCE
    Manufacturer
    FIBEROPTICS TECHNOLOGY, INC.
    Date Cleared
    2010-08-17

    (15 days)

    Product Code
    NTN, FCW
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBEROPTICS TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures.
    Device Description
    The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device.
    Ask a Question

    Page 1 of 1