FDA 510(k) Applications for Medical Device Product Code "FST"
(Light, Surgical, Fiberoptic)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K093386 | BFW, INC | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | 01/28/2010 |
| K051786 | DESIGNS FOR VISION, INC. | MELIDE FIBEROPTIC LIGHT | 08/15/2005 |
| K141330 | ENROXTECH, INC. | ENDO-CORD | 12/15/2014 |
| K061690 | GULF MEDICAL FIBEROPTICS | SURGICAL HEADLIGHT | 09/15/2006 |
| K200874 | Innovasis, Inc. | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | 06/30/2020 |
| K113697 | INVUITY, INC. | EIGR SURGICAL ILLUMINATION SYSTEM | 02/10/2012 |
| K090070 | INVUITY, INC. | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | 04/22/2009 |
| K991572 | ISOLUX AMERICA | ISOLUX SURGICAL HEADLIGHT | 07/08/1999 |
| K102266 | ISOLUX LLC | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | 09/24/2010 |
| K100388 | MEDICAL ILLUMINATION INTERNATIONAL, INC. | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | 06/22/2010 |
| K053227 | MEDICAL ILLUMINATION INTERNATIONAL, INC. | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | 01/13/2006 |
| K000728 | MEDTRONIC XOMED | MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBE | 03/21/2000 |
| K042034 | NUVASIVE, INC. | NUVASIVE MAXCESS LIGHT GUIDE | 10/26/2004 |
| K955510 | PRODUCTS FOR MEDICINE | X6000D SILENT SUN LIGHT SOURCE | 01/31/1996 |
| K113330 | SENSORMED | CABLECAP | 01/12/2012 |
| K101496 | SENSORMED | CABLECAP MODEL: WLF, STZ, ACM | 09/14/2010 |
| K082992 | SPINAL ELEMENTS, INC. | AXXION LIGHT GUIDE | 02/18/2009 |
| K100395 | STERIS Corporation | HARMONY VLED SURGICAL LIGHTNING SYSTEM | 03/17/2010 |
| K003577 | STERIS Corporation | STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT | 01/29/2001 |
| K122637 | STRYKER SPINE | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | 11/01/2012 |
| K083710 | THOMAS SURGICAL INSTRUMENTS, INC. | RETRACTOR LITE | 02/23/2009 |
| K080962 | THOMPSON SURGICAL INSTRUMENTS, INC. | LITE WAND II | 06/25/2008 |
| K972225 | UNIVERSAL FIBEROPTIC REPAIR, INC. | UFR FIBEROPTIC CABLE | 03/18/1998 |
| K071218 | WELCH ALLYN, INC. | PROXENON 350, MODEL 902XX | 06/14/2007 |
| K080367 | ZIMMER SPINE, INC. | ZIMMER MIS LIGHT | 02/22/2008 |
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