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) → FSS — Light, Surgical, Floor Standing # FSS · Light, Surgical, Floor Standing _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS ## Overview - **Product Code:** FSS - **Device Name:** Light, Surgical, Floor Standing - **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 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K091246](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K091246.md) | ILED 3 MOBILE (I300M), TRULIGHT 5500 MOBILE (T500M), TRULIGHT 5300 MOBILE (T300M) | Trumpf Medizin Systeme GmbH + Co. KG | Sep 28, 2009 | SESE | | [K003489](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K003489.md) | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | Medical Illumination International, Inc. | Feb 2, 2001 | SESE | | [K984124](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K984124.md) | AESCULAP XENON LIGHT SOURCE | Aesculap, Inc. | Feb 1, 1999 | SESE | | [K981962](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K981962.md) | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | Cuda Products Co. | Aug 18, 1998 | SESE | | [K981821](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K981821.md) | VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR | Angiolaz, Inc. | Jul 29, 1998 | SESE | | [K981469](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K981469.md) | CERMAX300 LIGHTSOURCE | Cuda Products Co. | Jul 9, 1998 | SESE | | [K980044](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K980044.md) | XENON 300MX | Perkinelmer Optoelectronics | Apr 3, 1998 | SESE | | [K970886](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K970886.md) | HANAULUX BLUE 80 HOSPITAL | Heraeus Med GmbH | Apr 16, 1997 | SESE | | [K961971](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K961971.md) | Q-5000 | Stryker Endoscopy | Jun 28, 1996 | SESE | | [K961074](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K961074.md) | LIGHTSOURCE OR ILLUMINATOR | Cuda Products Co. | Apr 30, 1996 | SESE | | [K930711](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K930711.md) | TRI*STAR | Light Technology Systems | Jul 30, 1993 | SESE | | [K910942](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K910942.md) | AC POWERED AND BATTERY POWERED MEDICAL EXAM. LIGHT | Mdt Biologic Co. | Jun 11, 1991 | SESE | | [K895950](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K895950.md) | MODEL FEL5100 FLOOR LIGHT | F.W. Lang Co. | Oct 31, 1989 | SESE | | [K893813](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K893813.md) | FLOOR STANDING, OPERATING AND EXAMINING LIGHT | Astralite Corp. | Jul 14, 1989 | SESE | | [K891759](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K891759.md) | KINETIC MODEL 330 | Kinetic Biomedical Services, Inc. | Apr 19, 1989 | SESE | | [K891758](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K891758.md) | KINETIC MODEL 132 | Kinetic Biomedical Services, Inc. | Apr 19, 1989 | SESE | | [K882333](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K882333.md) | FLOOR LIGHT | Commercial Products & Engineering Co. | Jun 23, 1988 | SESE | | [K880540](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K880540.md) | LIGHT, SURGICAL, FLOOR STANDING | Ferguson Medical | Feb 24, 1988 | SESE | | [K880198](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K880198.md) | GEMINI SURGICAL LIGHT | American Sterilizer Co. | Feb 10, 1988 | SESE | | [K860020](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS/K860020.md) | MINOR SURGERY LIGHT MODEL 2112 | Adel Medical , Ltd. | Jan 24, 1986 | SESE | ## Top Applicants - Cuda Products Co. — 3 clearances - Kinetic Biomedical Services, Inc. — 2 clearances - Trumpf Medizin Systeme GmbH + Co. KG — 1 clearance - Stryker Endoscopy — 1 clearance - Perkinelmer Optoelectronics — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FSS) **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