FSY · Light, Surgical, Ceiling Mounted
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FSY |
|---|---|
| Device Name | Light, Surgical, Ceiling Mounted |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.
Classification Rationale
Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142984 | Leo Minor | Sunnex, Inc. | Oct 29, 2014 | SESE |
| K142076 | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | Sep 30, 2014 | SESE |
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | Aug 7, 2014 | SESE |
| K132551 | ZF 720 | Umbel Corporation | Jun 30, 2014 | SESE |
| K140930 | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | Jun 9, 2014 | SESE |
| K140461 | MACH LED 2MC | Dr. Mach GmbH & Co. KG | Apr 3, 2014 | SESE |
| K140460 | MACH LED 2SC | Dr. Mach GmbH & Co. KG | Apr 3, 2014 | SESE |
| K132747 | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | Dec 30, 2013 | SESE |
| K132307 | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | Nov 5, 2013 | SESE |
| K131893 | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | Ajw Technology Consultants, Inc. | Oct 30, 2013 | SESE |
| K122875 | ORICARE L2700 | Oricare, Inc. | Dec 18, 2012 | SESE |
| K120392 | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | Feb 16, 2012 | SESE |
| K102758 | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | Oct 26, 2010 | SESE |
| K101537 | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | Sep 30, 2010 | SESE |
| 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 | Jul 20, 2010 | SESE |
| K093010 | MACH LED MC | Dr. Mach GmbH & Co. KG | Apr 1, 2010 | SESE |
| K093009 | MACH LED SC | Dr. Mach GmbH & Co. KG | Apr 1, 2010 | SESE |
| K090378 | CHROMOPHARE E 668 | Berchtold GmbH & Co. KG | Feb 23, 2009 | SESE |
| K083323 | NUVO VERDE LED LIGHTING SYSTEM | Nuvo, Inc. | Jan 28, 2009 | SESE |
| K083066 | CHROMOPHARE E 778 AND E 558 | Berchtold Holding GmbH | Oct 30, 2008 | SESE |
Top Applicants
- Berchtold Holding GmbH — 9 clearances
- Skytron, Div. the Kmw Group, Inc. — 6 clearances
- Burton Medical Products Corp. — 5 clearances
- Dr. Mach GmbH & Co. KG — 4 clearances
- Castle Co. — 3 clearances
