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Found 20 results
510(k) Data Aggregation
K Number
K093125Device Name
ALPHAXENON LIGHT 180 W AND 300 W
Manufacturer
GIMMI GMBH
Date Cleared
2010-01-27
(117 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K082925Device 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
876.1500Why 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
K070376Device Name
CONMED LINVATEC 300W XENON LIGHT SOURCE
Manufacturer
CONMED LINVATEC
Date Cleared
2007-08-20
(193 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K040949Device Name
VIADUCT MINISCOPE AND ACCESSORIES
Manufacturer
ACUEITY, INC.
Date Cleared
2004-05-07
(25 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K022490Device Name
KSEA MEDI PACK
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2003-09-29
(427 days)
Product Code
GCT, FET
Regulation Number
876.1500Why 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
K031994Device Name
LINVATEC 300W XENON LIGHT SOURCE
Manufacturer
LINVATEC CORP.
Date Cleared
2003-08-21
(55 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K023468Device Name
ENDOSCOPIC LIGHT SOURCE XL180/L3
Manufacturer
WORLD OF MEDICINE LEMKE GMBH
Date Cleared
2003-01-14
(90 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K021717Device 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
876.1500Why 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
K020889Device Name
ENDOSCOPIC LIGHT SOURCE XL202/L3
Manufacturer
WORLD OF MEDICINE LEMKE GMBH
Date Cleared
2002-06-05
(78 days)
Product Code
GCT
Regulation Number
876.1500Why 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
K013880Device Name
DAYLITE XENON LIGHT SOURCES
Manufacturer
DESIGNS FOR VISION, INC.
Date Cleared
2001-12-07
(14 days)
Product Code
GCT
Regulation Number
876.1500Why 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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