Product code HBI
- Device name
- Illuminator, Fiberoptic, Surgical Field
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223183 | Light-Guide Cables | Olympus Winter & Ibe GmbH | 2023-01-13 |
| K163185 | OptiLux LED Illuminator | Isolux, LLC | 2016-11-21 |
| K141781 | KOGENT SPETZLER LIGHTED SUCTION TUBES | Katalyst Surgical, LLC | 2015-04-09 |
| K111342 | LIGHT GUIDE CABLE | Schott North America | 2011-11-25 |
| K052979 | 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE | Isolux, LLC | 2005-10-31 |
| K021931 | ENDOSCOPIC FIBEROPTIC CABLE | Gulf Medical Fiberoptics | 2002-09-06 |
| K991208 | ENDOSCOPIC FIBEROPTIC CABLE | Isolux America | 1999-06-23 |
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | Cuda Products Co. | 1998-12-16 |
| K933593 | LUMINOUS 150 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1993-10-28 |
| K922837 | S1500 XENON LIGHT SOURCE | Endomedix | 1992-11-03 |
| K922462 | NEXTEC FIBEROPTIC CABLES | Nextec Corp. | 1992-09-21 |
| K921866 | LUMINOUS 250 FIBEROPTIC ILLUMINATOR | Progressive Dynamics, Inc. | 1992-07-08 |
| K920167 | NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL | Nextec Corp. | 1992-03-23 |
| K904616 | STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR | Storz Instrument Co. | 1991-04-19 |
| K904609 | XENON LIGHT SOURCE | Medical Dynamics, Inc. | 1990-12-18 |
| K904681 | VLS 5300 300W XENON LIGHT SOURCE | Vistek Corp. | 1990-12-18 |
| K901108 | FIBERLUME | Burton | 1990-03-28 |
| K896549 | STORZ FIBEROPTIC ENDO-ILLUMINATORS | Storz Instrument Co. | 1990-02-15 |
| K890398 | RYAN-STYLE DIRECTED INFUSION MANIPULATOR | Advanced Surgical Products, Inc. | 1989-02-17 |
| K883856 | FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 |
| K883857 | FIBEROPTIC WIRE PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 |
| K883858 | FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE | Advanced Surgical Products, Inc. | 1988-09-29 |
| K883201 | VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS | Vital Metrics, Inc. | 1988-09-26 |
| K882956 | VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION | Vital Metrics, Inc. | 1988-08-03 |
| K854587 | STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE | Storz Instrument Co. | 1986-02-04 |
| K853948 | MINNESOTA SCIENTIFIC, INC. OMNI-BEAM | Minnesota Scientific, Inc. | 1985-10-16 |
| K810300 | FIBER OPTIC ADAPTERS#60-0893 | Aspen Laboratories, Inc. | 1981-02-27 |
| K810299 | FIBER OPTIC ADAPTERS#60-0891 | Aspen Laboratories, Inc. | 1981-02-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00757770419067 | Bausch + Lomb | Bausch & Lomb Incorporated | 2026-04-30 |
| 00816744027728 | NICO Myriad SPECTRA | NICO CORPORATION | 2024-06-07 |
| 00816835024247 | OptiLux LED Illuminator | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024230 | OptiLux LED Illuminator | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024223 | OptiLux LED Illuminator | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024216 | OptiLux LED Illuminator | Medical Illumination International Inc. | 2023-10-02 |
| 00816744027704 | NICO Myriad NOVUS | NICO CORPORATION | 2023-04-28 |
| 00851925007779 | Strauss Surgical | AMERICAN MEDICAL ENDOSCOPY, INC. | 2022-05-18 |
| M678TX0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| 10884521176102 | Vital Vue | Covidien LP | 2016-09-24 |
| 10884521176119 | Vital Vue | Covidien LP | 2016-09-24 |
| 10884521176096 | Vital Vue | Covidien LP | 2016-09-24 |
| 10884521176089 | Vital Vue | Covidien LP | 2016-09-24 |
| 10884521176072 | Vital Vue | Covidien LP | 2016-09-24 |
| 00857580006089 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006027 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006034 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006041 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006058 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006065 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006072 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006010 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 00857580006003 | Fiber Optic Light Cable | GULF FIBEROPTICS, INC. | 2016-09-01 |
| 10856312006080 | Spetzler Lighted Suction Tube, 7 French, 140mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006066 | Spetzler Lighted Suction Tube, 5 French, 160mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006059 | Spetzler Lighted Suction Tube, 5 French, 140mm, Storz Conenctor | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006042 | Spetzler Lighted Suction Tube, 5 French, 120mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006035 | Spetzler Lighted Suction Tube, 3 French, 160mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006028 | Spetzler Lighted Suction Tube, 3 French, 140mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |
| 10856312006011 | Spetzler Lighted Suction Tube, 3 French, 120mm, Storz Connector | KATALYST SURGICAL LLC | 2016-07-18 |