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 |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | 2014-04-03 |
| K140460 | MACH LED 2SC | 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 |
|---|---|---|---|
| 10192253051988 | Devon | Cardinal Health 200, LLC | 2026-03-11 |
| 10192253052008 | Devon | Cardinal Health 200, LLC | 2025-04-14 |
| 10841736110536 | AURORA SURGICAL LIGHT SERIES | SKYTRON LLC | 2017-04-04 |
| M5759X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M575CPS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X4GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M575CPS30 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M5754X3GS10 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M57549X3GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M57548X4GS20 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-02-09 |
| M575GHC0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575HND0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575JZB0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M575SBR0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5759X3GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5758X4M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X4GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5754X3GSW0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5752X3W0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5752X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3W0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3SFT0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| M5751X3M0 | StarTrol | HUOT INSTRUMENTS, LLC | 2017-01-17 |
| 10884521138254 | Devon | Cardinal Health, Inc. | 2016-09-24 |
| 07613327296167 | Chromophare | Berchtold Holding GmbH | 2016-09-23 |
| 10841736100049 | Aurora Surgical Light Series | SKYTRON LLC | 2016-09-19 |
| 10841736100636 | Ergon Boom Series | SKYTRON LLC | 2016-09-19 |
| 10841736100841 | Ergon Boom Series | SKYTRON LLC | 2016-09-19 |
| 10841736100896 | Ergon Boom Series | SKYTRON LLC | 2016-09-19 |