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) → HBI — Illuminator, Fiberoptic, Surgical Field # HBI · Illuminator, Fiberoptic, Surgical Field _General, Plastic Surgery · 21 CFR 878.4580 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI ## Overview - **Product Code:** HBI - **Device Name:** Illuminator, Fiberoptic, Surgical Field - **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 28) Showing 20 most recent of 28 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K223183](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K223183.md) | Light-Guide Cables | Olympus Winter & Ibe GmbH | Jan 13, 2023 | SESE | | [K163185](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K163185.md) | OptiLux LED Illuminator | Isolux, LLC | Nov 21, 2016 | SESE | | [K141781](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K141781.md) | KOGENT SPETZLER LIGHTED SUCTION TUBES | Katalyst Surgical, LLC | Apr 9, 2015 | SESE | | [K111342](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K111342.md) | LIGHT GUIDE CABLE | Schott North America | Nov 25, 2011 | SESE | | [K052979](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K052979.md) | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | Isolux, LLC | Oct 31, 2005 | SESE | | [K021931](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K021931.md) | ENDOSCOPIC FIBEROPTIC CABLE | Gulf Medical Fiberoptics | Sep 6, 2002 | SESE | | [K991208](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K991208.md) | ENDOSCOPIC FIBEROPTIC CABLE | Isolux America | Jun 23, 1999 | SESE | | [K983277](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K983277.md) | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Cuda Products Co. | Dec 16, 1998 | SESE | | [K933593](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K933593.md) | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | Oct 28, 1993 | SESE | | [K922837](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K922837.md) | S1500 XENON LIGHT SOURCE | Endomedix | Nov 3, 1992 | SESE | | [K922462](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K922462.md) | NEXTEC FIBEROPTIC CABLES | Nextec Corp. | Sep 21, 1992 | SESE | | [K921866](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K921866.md) | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | Jul 8, 1992 | SESE | | [K920167](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K920167.md) | NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL | Nextec Corp. | Mar 23, 1992 | SESE | | [K904616](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K904616.md) | STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR | Storz Instrument Co. | Apr 19, 1991 | SESE | | [K904681](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K904681.md) | VLS 5300 300W XENON LIGHT SOURCE | Vistek Corp. | Dec 18, 1990 | SESE | | [K904609](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K904609.md) | XENON LIGHT SOURCE | Medical Dynamics, Inc. | Dec 18, 1990 | SESE | | [K901108](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K901108.md) | FIBERLUME | Burton | Mar 28, 1990 | SESE | | [K896549](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K896549.md) | STORZ FIBEROPTIC ENDO-ILLUMINATORS | Storz Instrument Co. | Feb 15, 1990 | SESE | | [K890398](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K890398.md) | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Advanced Surgical Products, Inc. | Feb 17, 1989 | SESE | | [K883858](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI/K883858.md) | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Advanced Surgical Products, Inc. | Sep 29, 1988 | SESE | ## Top Applicants - Advanced Surgical Products, Inc. — 4 clearances - Storz Instrument Co. — 3 clearances - Vital Metrics, Inc. — 2 clearances - Progressive Dynamics, Inc. — 2 clearances - Nextec Corp. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HBI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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