Product code FSY
- Device name
- Light, Surgical, Ceiling Mounted
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142984 | Leo Minor | Sunnex, Inc. | 2014-10-29 |
| K142076 | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | 2014-09-30 |
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | 2014-08-07 |
| K132551 | ZF 720 | Umbel Corporation | 2014-06-30 |
| K140930 | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | 2014-06-09 |
| K140460 | MACH LED 2SC | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | 2013-12-30 |
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | 2013-11-05 |
| K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | Ajw Technology Consultants, Inc. | 2013-10-30 |
| K122875 | ORICARE L2700 | Oricare, Inc. | 2012-12-18 |
| K120392 | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | 2012-02-16 |
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2010-10-26 |
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | 2010-09-30 |
| K100702 | 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 | Huot Instruments, LLC | 2010-07-20 |
| K093009 | MACH LED SC | Dr. Mach GmbH & Co. KG | 2010-04-01 |
| K093010 | MACH LED MC | Dr. Mach GmbH & Co. KG | 2010-04-01 |
| K090378 | CHROMOPHARE E 668 | Berchtold GmbH & Co. KG | 2009-02-23 |
| K083323 | NUVO VERDE LED LIGHTING SYSTEM | Nuvo, Inc. | 2009-01-28 |
| K083066 | CHROMOPHARE E 778 AND E 558 | Berchtold Holding GmbH | 2008-10-30 |
| K080857 | CHROMOPHARE E-SERIES | Berchtold Holding GmbH | 2008-04-10 |
| K072072 | HARMONY LED-1 SURGICAL LIGHTING SYSTEM | STERIS Corporation | 2007-10-05 |
| K071698 | AURORA LED SERIES SURGICAL LIGHTS | Skytron, Div. the Kmw Group, Inc. | 2007-07-06 |
| K070442 | POWERLED SURGICAL LIGHT SYSTEM | Maquet S.A. | 2007-03-16 |
| K063333 | M3 | Mavig GmbH | 2006-11-21 |
| K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006-06-22 |
| K060802 | VISUM LED SURGICAL LIGHTING SYSTEM | Stryker Communications Corp. | 2006-04-07 |
| K042395 | OUTPATIENT III MINOR SURGERY LIGHT | Burton Medical Products Corp. | 2004-12-01 |
| K042382 | DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD | Med-General Technologies, LLC | 2004-11-30 |
| K040735 | ALM X'TEN (X10) SURGICAL LIGHT SYSTEM | Alm S.A. | 2004-05-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04251339907317 | YLED-3F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 04251339907324 | YLED-2F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 04251339907348 | YLED-2F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 04251339907362 | YLED-2F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 04251339907379 | YLED-3F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 04251339907300 | YLED-3F (including Portegra) | MAVIG GmbH | 2026-07-21 |
| 03700712436247 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436353 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436254 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436261 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436278 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436285 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436292 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436308 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436315 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436322 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436339 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436346 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436230 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436223 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436216 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436209 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436193 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436186 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436179 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436162 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436155 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436148 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436131 | Volista | MAQUET SAS | 2026-07-20 |
| 03700712436124 | Volista | MAQUET SAS | 2026-07-20 |