Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580) → FTD — Lamp, Surgical # FTD · Lamp, Surgical _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD ## Overview - **Product Code:** FTD - **Device Name:** Lamp, Surgical - **Regulation:** [21 CFR 878.4580](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4580) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K133425.md) | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT | Engineered Medical Solutions Co., LLC | Dec 5, 2013 | SESE | | [K130513](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K130513.md) | VOLISTA 400; VOLISTA 600 | Maquet S.A.S. | May 8, 2013 | SESE | | [K123776](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K123776.md) | POLARIS 100/200 | Drager Medical GmbH | Mar 8, 2013 | SESE | | [K111020](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K111020.md) | ATRICURE DISSECTOR | AtriCure, Inc. | Jun 9, 2011 | SESE | | [K100234](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K100234.md) | HM-LAMP II | Hillusa, Inc. | Jul 8, 2010 | SESE | | [K100884](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K100884.md) | STRYKER KNIFELIGHT | Howmedica Osteonics Corp. | Jun 25, 2010 | SESE | | [K071180](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K071180.md) | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | Jun 20, 2007 | SESE | | [K053364](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K053364.md) | HALUX IRIS EXAMINATION AND SURGICAL LAMP | Waldmann Lighting | Feb 23, 2006 | SESE | | [K041681](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K041681.md) | ATRICURE DISSECTOR | AtriCure, Inc. | Jul 1, 2004 | SESE | | [K013242](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K013242.md) | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM | STERIS Corporation | Dec 13, 2001 | SESE | | [K010724](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K010724.md) | SOLA 700,SOLA 500, SOLA 300 | Drager Medizintechnik GmbH | Jun 7, 2001 | SESE | | [K003423](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K003423.md) | ST. FRANCIS OPERATING THEATRE LAMP, MODELS OLH01-125 AND LC-055 | St. Francis Medical Equipment Co., Ltd. | Feb 22, 2001 | SESE | | [K981717](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K981717.md) | STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR | Stryker Instruments | Jun 30, 1998 | SESE | | [K961122](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K961122.md) | STRYKER KNIFELIGHT | Stryker Instruments | Aug 22, 1996 | SESE | | [K954263](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K954263.md) | XE-LITE | Ophthalmic Technologies, Inc. | Oct 18, 1995 | SESD | | [K942553](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K942553.md) | GENESIS | Burton Medical Products Corp. | Jun 23, 1994 | SESE | | [K931675](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K931675.md) | MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS | Medline Industries, Inc. | Feb 22, 1994 | SESE | | [K932451](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K932451.md) | HANAULUX 2005 SURGICAL LIGHT | Heraeus Instruments GmbH | Nov 12, 1993 | SESE | | [K930897](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K930897.md) | MI-15 EXAM SURGICAL LIGHT | Medical Illumination, Inc. | Jun 25, 1993 | SESE | | [K895715](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD/K895715.md) | HANAULUX(R) 2000 | W.C. Heraeus GmbH | Oct 13, 1989 | SESE | ## Top Applicants - AtriCure, Inc. — 2 clearances - Burton Medical Products Corp. — 2 clearances - Engineered Medical Solutions Co., LLC — 2 clearances - Fiber Optics Engineering, Inc. — 2 clearances - Stryker Instruments — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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