FTD · Lamp, Surgical
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | FTD |
|---|---|
| Device Name | Lamp, Surgical |
| 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 29)
Showing 20 most recent of 29 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | Engineered Medical Solutions Co., LLC | Dec 5, 2013 | SESE |
| K130513 | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | May 8, 2013 | SESE |
| K123776 | POLARIS 100/200 | Drager Medical GmbH | Mar 8, 2013 | SESE |
| K111020 | ATRICURE DISSECTOR | AtriCure, Inc. | Jun 9, 2011 | SESE |
| K100234 | HM-LAMP II | Hillusa, Inc. | Jul 8, 2010 | SESE |
| K100884 | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | Jun 25, 2010 | SESE |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | Jun 20, 2007 | SESE |
| K053364 | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | Feb 23, 2006 | SESE |
| K041681 | ATRICURE DISSECTOR | AtriCure, Inc. | Jul 1, 2004 | SESE |
| K013242 | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | Dec 13, 2001 | SESE |
| K010724 | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | Jun 7, 2001 | SESE |
| K003423 | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | St. Francis Medical Equipment Co., Ltd. | Feb 22, 2001 | SESE |
| K981717 | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | Jun 30, 1998 | SESE |
| K961122 | STRYKER KNIFELIGHT | Stryker Instruments | Aug 22, 1996 | SESE |
| K954263 | XE-LITE | Ophthalmic Technologies, Inc. | Oct 18, 1995 | SESD |
| K942553 | GENESIS | Burton Medical Products Corp. | Jun 23, 1994 | SESE |
| K931675 | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Medline Industries, Inc. | Feb 22, 1994 | SESE |
| K932451 | HANAULUX 2005 SURGICAL LIGHT | Heraeus Instruments GmbH | Nov 12, 1993 | SESE |
| K930897 | MI-15 EXAM SURGICAL LIGHT | Medical Illumination, Inc. | Jun 25, 1993 | SESE |
| K895715 | HANAULUX(R) 2000 | W.C. Heraeus GmbH | Oct 13, 1989 | SESE |
Top Applicants
- Stryker Instruments — 2 clearances
- Fiber Optics Engineering, Inc. — 2 clearances
- Engineered Medical Solutions Co., LLC — 2 clearances
- Burton Medical Products Corp. — 2 clearances
- AtriCure, Inc. — 2 clearances
