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510(k) Data Aggregation

    K Number
    K093125
    Device Name
    ALPHAXENON LIGHT 180 W AND 300 W
    Manufacturer
    GIMMI GMBH
    Date Cleared
    2010-01-27

    (117 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AlphaXenon Light 300W and 180W light source is used with an endoscope to provide illumination during endoscopic procedures.
    Device Description
    AlphaXenon Light is a light generating device that when used with in conjunction with endoscopes to illuminate surgical site during Endoscopic procedures.
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    K Number
    K082925
    Device Name
    XENON-100 SCB LIGHT SOURCE, MODEL 20132620
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2008-12-18

    (78 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The KSEA Xenon-100 SCB Light Source is intended for use in combination with Karl Storz video-endoscopes for gastro-enterology or with Karl Storz endoscopes for general purpose endoscopy by qualified surgeons and is equipped with the SCB-feature which provides remote control of the light source for central operation, central display, automatic initial setting and interlocking operation to the Karl Storz SCB Control Computer (Karl Storz Communication Bus), to relay functions and controls on the SCB monitor.
    Device Description
    The Karl Xenon-100 SCB is a Light Source unit for Karl Storz video gastro-endoscopes.
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    K Number
    K070376
    Device Name
    CONMED LINVATEC 300W XENON LIGHT SOURCE
    Manufacturer
    CONMED LINVATEC
    Date Cleared
    2007-08-20

    (193 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ConMed Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
    Device Description
    The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.
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    K Number
    K040949
    Device Name
    VIADUCT MINISCOPE AND ACCESSORIES
    Manufacturer
    ACUEITY, INC.
    Date Cleared
    2004-05-07

    (25 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acueity ViaDuct Miniscope and Accessories are intended for use by a physician for viewing an interior cavity of the human body through either a natural opening or an incision. The accessory device is capable of grasping soft tissue for biopsy. The instruments are to be used for diagnostic or graspilly son thisue not intended for therapeutic use.
    Device Description
    Like the predicate devices, the Acueity ViaDuct Miniscope and Accessories consist of a semi-rigid fiberscope with an irrigating outer sheath or introducer capable of passing a biopsy needle to a soft tissue site for view or, to view and assess/biopsy soft tissue. The Acueity ViaDuct Miniscope and Accessories is also designed with an inner grasping sheath or tube that can be placed within the outer introducer, which together act as forceps capable of grasping soft tissue for biopsy. The combination of these devices allows access to very finite spaces.
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    K Number
    K022490
    Device Name
    KSEA MEDI PACK
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2003-09-29

    (427 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medi Pack is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures.
    Device Description
    The KSEA Medi Pack is a compact video camera system consisting of a camera control unit, a cold light source, a documentation module, a 6.4-inch high performance LCD video monitor, a keyboard, and a camera head.
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    K Number
    K031994
    Device Name
    LINVATEC 300W XENON LIGHT SOURCE
    Manufacturer
    LINVATEC CORP.
    Date Cleared
    2003-08-21

    (55 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Linvatec 300W Xenon Light Source is intended to be used with an endoscope to provide illumination during endoscopic procedures.
    Device Description
    The Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The Linvatec 300W Xenon Light Source is capable of interfacing with the ConMed I.S. Operating Room Control System to allow an alternate means for user control.
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    K Number
    K023468
    Device Name
    ENDOSCOPIC LIGHT SOURCE XL180/L3
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2003-01-14

    (90 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL180/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
    Device Description
    The Endoscopic Light Source XL180/L3 uses a 180 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 6000 °K and the lamp life is approximately 500 hours.
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    K Number
    K021717
    Device Name
    ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-08-20

    (89 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL300/L5 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
    Device Description
    The Endoscopic Light Source XL300/L5 uses a 300 W xenon lamp to provide illumination during endoscopic diagnostic and surgical procedures through a fiber optic cable, which is connected to the device. Brightness can be adjusted manually. The color temperature of the xenon lamp is approximately 5600 °K and the lamp life is approximately 500 hours.
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    K Number
    K020889
    Device Name
    ENDOSCOPIC LIGHT SOURCE XL202/L3
    Manufacturer
    WORLD OF MEDICINE LEMKE GMBH
    Date Cleared
    2002-06-05

    (78 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures. The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.
    Device Description
    The Endoscopic Light Source XL202/L3 uses a 180 W xenon lamp to provide illumination during endoscopic surgery through a fiber optic cable, which is connected to the device. Furthermore, the light source can be equipped with an additional 150 W halogen lamp for diagnostic applications in endoscopy. The 150 W halogen lamp also function as a backup up lamp to avoid interrupting a procedure in case of a malfunction of the xenon lamp. The color temperature of the xenon lamp and halogen lamp is approximately 6000 % and 3400 % respectively, the lamp life approximately 500 hours and 50 h respectively.
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    K Number
    K013880
    Device Name
    DAYLITE XENON LIGHT SOURCES
    Manufacturer
    DESIGNS FOR VISION, INC.
    Date Cleared
    2001-12-07

    (14 days)

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

    GCT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Daylite Xenon Light Source is indicated for use in surgery and medical applications where high intensity illumination is required
    Device Description
    The Daylite XeNon Light Sources are comprised of high intensity xenon light sources, fiberoptic cables and fiberoptic headsets. The Designs for Vision Daylite Light Sources are supplied with headsets that were first placed into service prior to 1976 and are preamendment devices. The Designs for Vision headsets have been marketed since the early 1970's with a long history of safe use in the surgical suite. The headsets are either coaxial, bifurcated, or focusable designs. The light source includes a universal chuck for fiberoptic cable attachment. The universal chuck accepts various sizes of light cables. The XeNon Light sources provide either 180-watt or 300-watt power output and contain a continuous illumination level adjustment which provides 6000°K color temperature light.
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