FDA 510(k) Applications for Medical Device Product Code "FCW"
(Light Source, Fiberoptic, Routine)

FDA 510(k) Number Applicant Device Name Decision Date
K032430 ACUEITY, INC. ACUEITY MEDICAL LIGHT SOURCE 09/05/2003
K992447 ANGIOLAZ, INC. 50 W METAL HALIDE ILLUMINATOR, VES 0501. 10/20/1999
K012265 CIRCON VIDEO METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 10/17/2001
K963043 CORIN U.S.A. ENDOSPOT 09/20/1996
K993300 FIBER IMAGING TECHNOLOGIES, INC. COLDLIGHTSOURCE PL3000 11/05/1999
K964586 IBA/GRIFFITH PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 01/17/1997
K081477 INTEGRA LUXTEC, INC. LUXTEC MLX LIGHT SOURCE 06/18/2008
K091968 KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C 09/14/2009
K123956 KARL STORZ ENDOSCOPY-AMERICA, INC. POWER LED 175 01/25/2013
K131226 NOVAPROBE INCORPORATED NOVAPROBE LED LIGHT SOURCE 07/24/2014
K123359 OLIVE MEDICAL CORP. OVS1 VIDEO SYSTEM 12/19/2012
K121724 RICHARD WOLF MEDICAL INSTRUMENTS CORP. ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 09/20/2012
K082813 STRYKER CORP. STRYKER LED LIGHTSOURCE 12/19/2008
K093792 SUNOPTIC TECHNOLOGIES, LLC LED LIGHT SOURCE 03/18/2010
K970598 UROHEALTH, INC. INTEGRATED VISUALIZATION SYSTEM 03/12/1997
K000229 VIDEOLABS, INC. VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE 03/21/2000


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