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) → FTA — Light, Surgical, Accessories # FTA · Light, Surgical, Accessories _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA ## Overview - **Product Code:** FTA - **Device Name:** Light, Surgical, Accessories - **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 26) Showing 20 most recent of 26 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K150532](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K150532.md) | Universal Light Handle Cover, Light Handle Cover | Key Surgical, Inc. | Sep 22, 2015 | SESE | | [K142386](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K142386.md) | Operating Room Light Handle Adapter | Litex Manufacturing, Inc. | Sep 29, 2014 | SESE | | [K133554](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K133554.md) | SURGICAL LIGHT HANDLE COVER | Microtek Medical, Inc. an Ecolab Company | Apr 8, 2014 | SESE | | [K133413](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K133413.md) | IDSS SLC | Black Diamond Video | Jan 7, 2014 | SESE | | [K112133](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K112133.md) | OASYS SURGICAL LIGHT CONTROLLER | Oasys Healthcare | Mar 1, 2012 | SESE | | [K102791](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K102791.md) | EASYSUITE SURGICAL LIGHT CONTROL (ESLC) | Image Stream Medical, Inc. | Nov 23, 2010 | SESE | | [K081698](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K081698.md) | MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC) | Image Stream Medical, Inc. | Jul 30, 2008 | SESE | | [K053321](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K053321.md) | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | Xodus Medical, Inc. | Jan 19, 2006 | SESE | | [K051505](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K051505.md) | SCB/STERIS OR-LIGHT INTERFACE BOX | KARL STORZ Endoscopy-America, Inc. | Aug 11, 2005 | SESE | | [K023704](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K023704.md) | KSEA SCB ACC CONTROL | KARL STORZ Endoscopy-America, Inc. | Jan 30, 2003 | SESE | | [K020640](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K020640.md) | KSEA SCB MEDIA CONTROL | KARL STORZ Endoscopy-America, Inc. | May 28, 2002 | SESE | | [K020304](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K020304.md) | DISPOSABLE LIGHT HANDLE AND ADAPTOR | Aspen Surgical Products, Inc. | Feb 14, 2002 | SESE | | [K993089](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K993089.md) | DEROYAL DISPOSABLE RIGID LIGHT HANDLE AND ADAPTER | Deroyal Cardiovascular, Inc. | Oct 14, 1999 | SESE | | [K954940](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K954940.md) | MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE | Mdt Biologic Co. | Jan 17, 1996 | SESE | | [K935102](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K935102.md) | SATURN LIGHT | Burton Medical Products Corp. | Jun 27, 1994 | SESE | | [K915068](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K915068.md) | PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER | American Medical Mfg., Inc. | Feb 6, 1992 | SESE | | [K901154](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K901154.md) | MICROTEK'S SURGICAL LAMP HANDLE & COVER | Microbio-Medics, Inc. | Mar 20, 1990 | SESE | | [K894397](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K894397.md) | WELCON LIGHT HANDLE | Welcon, Inc. | Aug 10, 1989 | SESE | | [K890867](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K890867.md) | TC SYSTEM-COVER | Transmedical Corp. | Mar 14, 1989 | SESE | | [K890866](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA/K890866.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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