FDA 510(k) Applications for Medical Device Product Code "GCT"
(Light Source, Endoscope, Xenon Arc)

FDA 510(k) Number Applicant Device Name Decision Date
K040949 ACUEITY, INC. VIADUCT MINISCOPE AND ACCESSORIES 05/07/2004
K971057 COGENT LIGHT TECHNOLOGIES, INC. COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM 03/28/1997
K070376 CONMED LINVATEC CONMED LINVATEC 300W XENON LIGHT SOURCE 08/20/2007
K981804 CONTEC MEDICAL VISION, LTD. XENON LIGHT SOURCE MODEL LS6000 07/24/1998
K982962 CONTEC MEDICAL VISION, LTD. XENON LIGHT SOURCE, MODELS LS6180, LS6035 09/23/1998
K963044 CORIN U.S.A. ENDOBEAM 09/20/1996
K013880 DESIGNS FOR VISION, INC. DAYLITE XENON LIGHT SOURCES 12/07/2001
K962365 DSP WORLDWIDE XENON LIGHTSOURCE 07/18/1996
K093125 GIMMI GMBH ALPHAXENON LIGHT 180 W AND 300 W 01/27/2010
K022490 KARL STORZ ENDOSCOPY-AMERICA, INC. KSEA MEDI PACK 09/29/2003
K082925 KARL STORZ ENDOSCOPY-AMERICA, INC. XENON-100 SCB LIGHT SOURCE, MODEL 20132620 12/18/2008
K992540 LASER OPTIK SYSTEME GMBH & CO. KG XENON LIGHT SOURCE PES 1 09/14/1999
K031994 LINVATEC CORP. LINVATEC 300W XENON LIGHT SOURCE 08/21/2003
K963227 PRODUCTS FOR MEDICINE WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 10/23/1996
K983628 RICHARD WOLF MEDICAL INSTRUMENTS CORP. XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 12/11/1998
K992050 WALTER LORENZ SURGICAL, INC. LUMENON XENON LIGHT SOURCE 09/14/1999
K980281 WELCH ALLYN, INC. WELCH ALLYN XENON 300 LIGHT SOURCE 02/27/1998
K023468 WORLD OF MEDICINE LEMKE GMBH ENDOSCOPIC LIGHT SOURCE XL180/L3 01/14/2003
K020889 WORLD OF MEDICINE LEMKE GMBH ENDOSCOPIC LIGHT SOURCE XL202/L3 06/05/2002
K021717 WORLD OF MEDICINE LEMKE GMBH ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 08/20/2002


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