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) → FSY — Light, Surgical, Ceiling Mounted # FSY · Light, Surgical, Ceiling Mounted _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY ## Overview - **Product Code:** FSY - **Device Name:** Light, Surgical, Ceiling Mounted - **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 74) Showing 20 most recent of 74 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K142984](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K142984.md) | Leo Minor | Sunnex, Inc. | Oct 29, 2014 | SESE | | [K142076](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K142076.md) | CLAVEGUARD FREEDOM SURGICAL LIGHT | Dickson & Dickson Healthcare (Us), Inc. | Sep 30, 2014 | SESE | | [K140812](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K140812.md) | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | Medical Illumination International, Inc. | Aug 7, 2014 | SESE | | [K132551](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K132551.md) | ZF 720 | Umbel Corporation | Jun 30, 2014 | SESE | | [K140930](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K140930.md) | VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES | Convida Healthcare & Systems Corporation | Jun 9, 2014 | SESE | | [K140461](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K140461.md) | MACH LED 2MC | Dr. Mach GmbH & Co. KG | Apr 3, 2014 | SESE | | [K140460](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K140460.md) | MACH LED 2SC | Dr. Mach GmbH & Co. KG | Apr 3, 2014 | SESE | | [K132747](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K132747.md) | VISUM BLADE LED SURGICAL LIGHTING SYSTEM | Stryker Communications | Dec 30, 2013 | SESE | | [K132307](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K132307.md) | VIDA LED SURGICAL LIGHTING SYSTEM | Convida Healthcare & Systems Corporation | Nov 5, 2013 | SESE | | [K131893](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K131893.md) | AMICO CE SERIES SURGICAL LIGHTS, MIRA LED SERIES MINOR SURGICAL LIGHTS | Ajw Technology Consultants, Inc. | Oct 30, 2013 | SESE | | [K122875](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K122875.md) | ORICARE L2700 | Oricare, Inc. | Dec 18, 2012 | SESE | | [K120392](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K120392.md) | CHROMOPHARE F 628 AND F 528 | Berchtold GmbH & Co. KG | Feb 16, 2012 | SESE | | [K102758](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K102758.md) | TRULIGHT 5520 AND TRULIGHT 5320 | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | Oct 26, 2010 | SESE | | [K101537](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K101537.md) | AIM 200, MAJOR SURGICAL LIGHT | Burton Medical Products Corp. | Sep 30, 2010 | SESE | | [K100702](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K100702.md) | 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K093010.md) | MACH LED MC | Dr. Mach GmbH & Co. KG | Apr 1, 2010 | SESE | | [K093009](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K093009.md) | MACH LED SC | Dr. Mach GmbH & Co. KG | Apr 1, 2010 | SESE | | [K090378](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K090378.md) | CHROMOPHARE E 668 | Berchtold GmbH & Co. KG | Feb 23, 2009 | SESE | | [K083323](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K083323.md) | NUVO VERDE LED LIGHTING SYSTEM | Nuvo, Inc. | Jan 28, 2009 | SESE | | [K083066](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY/K083066.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSY) **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. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com