FTA · Light, Surgical, Accessories
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FTA |
|---|---|
| Device Name | Light, Surgical, Accessories |
| 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 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K150532 | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | Sep 22, 2015 | SESE |
| K142386 | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | Sep 29, 2014 | SESE |
| K133554 | SURGICAL LIGHT HANDLE COVER | Microtek Medical, Inc. an Ecolab Company | Apr 8, 2014 | SESE |
| K133413 | IDSS SLC | Black Diamond Video | Jan 7, 2014 | SESE |
| K112133 | OASYS SURGICAL LIGHT CONTROLLER | Oasys Healthcare | Mar 1, 2012 | SESE |
| K102791 | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | Image Stream Medical, Inc. | Nov 23, 2010 | SESE |
| K081698 | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | Jul 30, 2008 | SESE |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | Jan 19, 2006 | SESE |
| K051505 | SCB/STERIS OR-LIGHT INTERFACE BOX | KARL STORZ Endoscopy-America, Inc. | Aug 11, 2005 | SESE |
| K023704 | KSEA SCB ACC CONTROL | KARL STORZ Endoscopy-America, Inc. | Jan 30, 2003 | SESE |
| K020640 | KSEA SCB MEDIA CONTROL | KARL STORZ Endoscopy-America, Inc. | May 28, 2002 | SESE |
| K020304 | DISPOSABLE LIGHT HANDLE AND ADAPTOR | Aspen Surgical Products, Inc. | Feb 14, 2002 | SESE |
| K993089 | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | Deroyal Cardiovascular, Inc. | Oct 14, 1999 | SESE |
| K954940 | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | Jan 17, 1996 | SESE |
| K935102 | SATURN LIGHT | Burton Medical Products Corp. | Jun 27, 1994 | SESE |
| K915068 | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | Feb 6, 1992 | SESE |
| K901154 | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | Mar 20, 1990 | SESE |
| K894397 | WELCON LIGHT HANDLE | Welcon, Inc. | Aug 10, 1989 | SESE |
| K890867 | TC SYSTEM-COVER | Transmedical Corp. | Mar 14, 1989 | SESE |
| K890866 | TC SYSTEM-HANDLE | Transmedical Corp. | Mar 14, 1989 | SESE |
Top Applicants
- KARL STORZ Endoscopy-America, Inc. — 3 clearances
- Image Stream Medical, Inc. — 2 clearances
- Transmedical Corp. — 2 clearances
- American Medical Mfg., Inc. — 1 clearance
- Aspen Surgical Products, Inc. — 1 clearance
