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) → FST — Light, Surgical, Fiberoptic # FST · Light, Surgical, Fiberoptic _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST ## Overview - **Product Code:** FST - **Device Name:** Light, Surgical, Fiberoptic - **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) - **3rd-party reviewable:** yes ## 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 45) Showing 20 most recent of 45 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K200874](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K200874.md) | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End | Innovasis, Inc. | Jun 30, 2020 | SESE | | [K141330](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K141330.md) | ENDO-CORD | Enroxtech, Inc. | Dec 15, 2014 | SESE | | [K122637](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K122637.md) | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 | Stryker Spine | Nov 1, 2012 | SESE | | [K113697](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K113697.md) | EIGR SURGICAL ILLUMINATION SYSTEM | Invuity, Inc. | Feb 10, 2012 | SESE | | [K113330](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K113330.md) | CABLECAP | Sensormed | Jan 12, 2012 | SESE | | [K102266](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K102266.md) | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | Isolux, LLC | Sep 24, 2010 | SESE | | [K101496](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K101496.md) | CABLECAP MODEL: WLF, STZ, ACM | Sensormed | Sep 14, 2010 | SESE | | [K100388](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K100388.md) | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | Medical Illumination International, Inc. | Jun 22, 2010 | SESE | | [K100395](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K100395.md) | HARMONY VLED SURGICAL LIGHTNING SYSTEM | STERIS Corporation | Mar 17, 2010 | SESE | | [K093386](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K093386.md) | CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST | Bfw, Inc. | Jan 28, 2010 | SESE | | [K090070](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K090070.md) | INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM | Invuity, Inc. | Apr 22, 2009 | SESE | | [K083710](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K083710.md) | RETRACTOR LITE | Thomas Surgical Instruments, Inc. | Feb 23, 2009 | SESE | | [K082992](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K082992.md) | AXXION LIGHT GUIDE | Spinal Elements, Inc. | Feb 18, 2009 | SESE | | [K080962](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K080962.md) | LITE WAND II | Thompson Surgical Instruments, Inc. | Jun 25, 2008 | SESE | | [K080367](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K080367.md) | ZIMMER MIS LIGHT | Zimmer Spine, Inc. | Feb 22, 2008 | SESE | | [K071218](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K071218.md) | PROXENON 350, MODEL 902XX | Welch Allyn, Inc. | Jun 14, 2007 | SESE | | [K061690](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K061690.md) | SURGICAL HEADLIGHT | Gulf Medical Fiberoptics | Sep 15, 2006 | SESE | | [K053227](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K053227.md) | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | Medical Illumination International, Inc. | Jan 13, 2006 | SESE | | [K051786](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K051786.md) | MELIDE FIBEROPTIC LIGHT | Designs For Vision, Inc. | Aug 15, 2005 | SESE | | [K042034](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST/K042034.md) | NUVASIVE MAXCESS LIGHT GUIDE | Nuvasive, Inc. | Oct 26, 2004 | SESE | ## Top Applicants - Advanced Surgical Products, Inc. — 5 clearances - Cuda Products Co. — 3 clearances - Invuity, Inc. — 2 clearances - Medical Illumination International, Inc. — 2 clearances - STERIS Corporation — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FST) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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