FDA 510(k) Applications for Medical Device Product Code "FSY"
(Light, Surgical, Ceiling Mounted)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131893 | AJW TECHNOLOGY CONSULTANTS, INC. | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | 10/30/2013 |
| K030906 | ALM | AXCEL SURGICAL LIGHT | 04/23/2003 |
| K040735 | ALM S.A. | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM | 05/21/2004 |
| K040015 | ALM S.A. | MODIFICATION TO PRISMALIX SURGICAL LIGHT | 01/21/2004 |
| K982063 | ALM SURGICAL EQUIPMENT, INC. | ALM PRISMALIX (PRX) SURGICAL LIGHT | 09/22/1998 |
| K090378 | BERCHTOLD GMBH & CO. KG | CHROMOPHARE E 668 | 02/23/2009 |
| K120392 | BERCHTOLD GMBH & CO. KG | CHROMOPHARE F 628 AND F 528 | 02/16/2012 |
| K965130 | BERCHTOLD HOLDING GMBH | CHROMOPHARE | 07/14/1997 |
| K974433 | BERCHTOLD HOLDING GMBH | CHROMOPHARE D 500, CHROMOPHARE D 530 | 02/20/1998 |
| K990656 | BERCHTOLD HOLDING GMBH | CHROMOPHARE D 530 LDR SURGICAL LIGHT | 07/20/1999 |
| K991527 | BERCHTOLD HOLDING GMBH | CHROMOPHARE D500, D530, D650 | 05/27/1999 |
| K083066 | BERCHTOLD HOLDING GMBH | CHROMOPHARE E 778 AND E 558 | 10/30/2008 |
| K080857 | BERCHTOLD HOLDING GMBH | CHROMOPHARE E-SERIES | 04/10/2008 |
| K024132 | BERCHTOLD HOLDING GMBH | CHROMOPHARE X 65 | 03/21/2003 |
| K101537 | BURTON MEDICAL PRODUCTS CORP. | AIM 200, MAJOR SURGICAL LIGHT | 09/30/2010 |
| K961843 | BURTON MEDICAL PRODUCTS CORP. | GENIE | 08/22/1996 |
| K963682 | BURTON MEDICAL PRODUCTS CORP. | GENIE' SINGLE CEILING AND DOUBLE CEILING | 11/13/1996 |
| K042395 | BURTON MEDICAL PRODUCTS CORP. | OUTPATIENT III MINOR SURGERY LIGHT | 12/01/2004 |
| K000639 | BURTON MEDICAL PRODUCTS CORP. | VISIONARY 2000 | 05/25/2000 |
| K031979 | CONMED INTEGRATED SYSTEMS (CMIS) | CONMED INTEGRATED SYSTEMS NURSES ASSISTANT | 07/25/2003 |
| K132307 | CONVIDA HEALTHCARE & SYSTEMS CORPORATION | VIDA LED SURGICAL LIGHTING SYSTEM | 11/05/2013 |
| K140930 | CONVIDA HEALTHCARE & SYSTEMS CORPORATION | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | 06/09/2014 |
| K142076 | DICKSON & DICKSON HEALTHCARE (US), INC | CLAVEGUARD FREEDOM SURGICAL LIGHT | 09/30/2014 |
| K140461 | DR. MACH GMBH & CO. KG | MACH LED 2MC | 04/03/2014 |
| K140460 | DR. MACH GMBH & CO. KG | MACH LED 2SC | 04/03/2014 |
| K093010 | DR. MACH GMBH & CO. KG | MACH LED MC | 04/01/2010 |
| K093009 | DR. MACH GMBH & CO. KG | MACH LED SC | 04/01/2010 |
| K984611 | DRAGER MEDIZINTECHNIK GMBH | DRAGER SOLA SERIES, MODELS 1000/700/500/300 | 03/29/1999 |
| K993242 | GETINGE/CASTLE, INC. | CASTLE SURGICAL LIGHT, MODEL 3000 | 11/08/1999 |
| K974084 | GETINGE/CASTLE, INC. | GETINGE/CASTLE OPTIVIEW SERIES SURGICAL LIGHT | 03/03/1998 |
| K954169 | HERAEUS MED GMBH | HANAULUX BLUE 30 & 80 | 02/01/1996 |
| K973466 | HERAEUS MED GMBH | HANAULUX BLUE 75 AND HANAULUX BLUE 120 | 10/24/1997 |
| K981081 | HILL-ROM, INC. | BRIGHTSTAR | 04/29/1998 |
| K100702 | HUOT INSTRUMENTS, LLC | STARTROL LED LIGHTING SYSTEMS (X=# OF PODS, Y=# OF LEDS, N=TO MOUNTING STYLE) MODEL X X Y -N-S-W. X=NUMBER OF LIGHT PODS | 07/20/2010 |
| K070442 | MAQUET S.A. | POWERLED SURGICAL LIGHT SYSTEM | 03/16/2007 |
| K063333 | MAVIG GMBH | M3 | 11/21/2006 |
| K042382 | MED-GENERAL TECHNOLOGIES LLC | DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD | 11/30/2004 |
| K140812 | MEDICAL ILLUMINATION INTERNATIONAL, INC. | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | 08/07/2014 |
| K083323 | NUVO, INC. | NUVO VERDE LED LIGHTING SYSTEM | 01/28/2009 |
| K122875 | ORICARE, INC. | ORICARE L2700 | 12/18/2012 |
| K071698 | SKYTRON, DIV. THE KMW GROUP, INC. | AURORA LED SERIES SURGICAL LIGHTS | 07/06/2007 |
| K992090 | SKYTRON, DIV. THE KMW GROUP, INC. | MILLENNIUM GOLD | 09/08/1999 |
| K002463 | SKYTRON, DIV. THE KMW GROUP, INC. | STELLAR | 11/08/2000 |
| K021585 | SKYTRON, DIV. THE KMW GROUP, INC. | STELLAR SERIES SURGICAL LIGHTS WITH HERMES | 11/13/2002 |
| K072072 | STERIS Corporation | HARMONY LED-1 SURGICAL LIGHTING SYSTEM | 10/05/2007 |
| K132747 | STRYKER COMMUNICATIONS | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | 12/30/2013 |
| K060802 | STRYKER COMMUNICATIONS CORP. | VISUM LED SURGICAL LIGHTING SYSTEM | 04/07/2006 |
| K031068 | Stryker Endoscopy | STRYKER VISUM SURGICAL LIGHTING SYSTEM | 08/12/2003 |
| K142984 | SUNNEX, INC. | Leo Minor | 10/29/2014 |
| K061317 | TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG | ILED | 06/22/2006 |
| K102758 | TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG | TRULIGHT 5520 AND TRULIGHT 5320 | 10/26/2010 |
| K011693 | TRUMPF MEDICAL SYSTEMS, INC. | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 | 06/13/2001 |
| K132551 | UMBEL CORPORATION | ZF 720 | 06/30/2014 |
| K010716 | VAL MED CORP. | VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB | 05/30/2001 |
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