HBI · Illuminator, Fiberoptic, Surgical Field
General, Plastic Surgery · 21 CFR 878.4580 · Class 2
Overview
| Product Code | HBI |
|---|---|
| Device Name | Illuminator, Fiberoptic, Surgical Field |
| Regulation | 21 CFR 878.4580 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | Light-Guide Cables | Olympus Winter & Ibe GmbH | Jan 13, 2023 | SESE |
| K163185 | OptiLux LED Illuminator | Isolux, LLC | Nov 21, 2016 | SESE |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | Katalyst Surgical, LLC | Apr 9, 2015 | SESE |
| K111342 | LIGHT GUIDE CABLE | Schott North America | Nov 25, 2011 | SESE |
| K052979 | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | Isolux, LLC | Oct 31, 2005 | SESE |
| K021931 | ENDOSCOPIC FIBEROPTIC CABLE | Gulf Medical Fiberoptics | Sep 6, 2002 | SESE |
| K991208 | ENDOSCOPIC FIBEROPTIC CABLE | Isolux America | Jun 23, 1999 | SESE |
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Cuda Products Co. | Dec 16, 1998 | SESE |
| K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | Oct 28, 1993 | SESE |
| K922837 | S1500 XENON LIGHT SOURCE | Endomedix | Nov 3, 1992 | SESE |
| K922462 | NEXTEC FIBEROPTIC CABLES | Nextec Corp. | Sep 21, 1992 | SESE |
| K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | Jul 8, 1992 | SESE |
| K920167 | NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL | Nextec Corp. | Mar 23, 1992 | SESE |
| K904616 | STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR | Storz Instrument Co. | Apr 19, 1991 | SESE |
| K904681 | VLS 5300 300W XENON LIGHT SOURCE | Vistek Corp. | Dec 18, 1990 | SESE |
| K904609 | XENON LIGHT SOURCE | Medical Dynamics, Inc. | Dec 18, 1990 | SESE |
| K901108 | FIBERLUME | Burton | Mar 28, 1990 | SESE |
| K896549 | STORZ FIBEROPTIC ENDO-ILLUMINATORS | Storz Instrument Co. | Feb 15, 1990 | SESE |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Advanced Surgical Products, Inc. | Feb 17, 1989 | SESE |
| K883858 | 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
