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510(k) Data Aggregation

    K Number
    K141164
    Device Name
    ARTEMIS LIGHT ENGINE
    Manufacturer
    QUEST MEDICAL IMAGING
    Date Cleared
    2015-03-16

    (315 days)

    Product Code
    NTN
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Artemis Light Engine is a primary LED light source when used in conjunction with laparoscopes or surgical cameras to illuminated surgical sites that allow observation or manipulation of body cavities, hollow organs, and canals.
    Device Description
    The Light Engine is a family of light engines that are designed for laboratory and clinical use in applications. The Light Engine provides a light source of which the intensity can be controlled via a PC. The output power of the Light Engine is calibrated as to provide a linear response over the full range of intensity and life-time. The Light Engine can be controlled by an external software device, or directly with the serial port provided by the USB interface (RS232-via-USB).
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    K Number
    K133311
    Device Name
    ENDOLED
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Date Cleared
    2014-07-30

    (275 days)

    Product Code
    NTN
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoLED is to be used in conjunction with endoscopic devices to provide illumination and visualization of optical images.
    Device Description
    The EndoLED is a lightweight portable lamp for the use with endoscopes. The device is battery-operated and uses LEDs to illuminate the area of interest. For the users convenience, the EndoLED come in different designs, the straight and the angled one. The accessories comprise adapters for the use of the EndoLED with different types of endoscopes.
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    K Number
    K130819
    Device Name
    CLL- V1 LIGHT SOURCE
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Date Cleared
    2013-06-19

    (86 days)

    Product Code
    NTN, FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
    Device Description
    The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.
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    K Number
    K122831
    Device Name
    VIDEO SYSTEM CENTER
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Date Cleared
    2012-12-14

    (88 days)

    Product Code
    NTN, FET, NWB
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This video system center is intended to be used with OLYMPUS video converter, camera heads, endoscopes, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation.
    Device Description
    The VIDEO SYSTEM CENTER OLYMPUS CV-170 is intended for endoscopic diagnosis, treatment and video observation. The CV-170 is a device which integrates the video processor and the light source. Thus, the CV-170 itself could emit light, capture and process the endoscopic image, and transmit signal to display it on the monitor. The main function of the CV-170 is NBI observation, LED lamp examination, Noise reduction function, Pre-freeze feature, and Color correction.
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    K Number
    K113679
    Device Name
    LUCEA LED SURGICAL LIGHT SYSTEM
    Manufacturer
    MAQUET SAS
    Date Cleared
    2012-01-12

    (29 days)

    Product Code
    NTN, FSS, FTD
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAQUET LUCEA LED® Surgical Light Systems are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
    Device Description
    MAQUET LUCEA LED® Surgical Light Systems have been developed in order to provide MAQUET EUGEAEED Surgied Lightnology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. functional shape oners an cindical provide hights provide high quality illumination Designed for minor ourgory, without any compromises on the major enhancements offered by MAQUET surgical lights. The LUCEA LED® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations.
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    K Number
    K103813
    Device Name
    SOPRO 281
    Manufacturer
    SOPRO
    Date Cleared
    2011-03-22

    (83 days)

    Product Code
    NTN, FCW
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy
    Device Description
    The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
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    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?
    Product Code :

    NTN

    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.
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    K Number
    K091829
    Device Name
    PLS PORTABLE LIGHT SOURCE
    Manufacturer
    OPTIM, INC.
    Date Cleared
    2009-07-28

    (39 days)

    Product Code
    NTN
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
    Device Description
    The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
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    K Number
    K090601
    Device Name
    FSC 2
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2009-05-11

    (67 days)

    Product Code
    NTN, LED, XXX
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    NTN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FSC 2 is intended to be used in conjunction with endoscopic devices to provide illumination and video visualization of optical images to visualize and observe body spaces.
    Device Description
    The Schoelly FSC 2 is a camera hand piece with built-in LED illumination intended to be used with Schoelly endoscopes. The light source provides illumination to the area under endoscopic examination. The compact camera component attaches to the proximal eyepiece of the endoscope via the Flexilock connector. Optically captured images are transferred to the camera. converted to an electrical signal, and amplified for output to accessories such as a computer.
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