Product Code: HBI FDA class 2 21 CFR 878.4580

Illuminator, Fiberoptic, Surgical Field

General, Plastic Surgery

The Fiberoptic Surgical Field Illuminator is a light delivery device that uses fiberoptic technology to direct bright, focused illumination into deep or narrow surgical cavities, improving visibility during procedures in general and plastic surgery. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HBI under regulation 21 CFR 878.4580 in the General, Plastic Surgery specialty. It is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code HBI in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: HBI
Device Class: FDA class 2
Regulation Number: 878.4580
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223183	Light-Guide Cables	Jan 13, 2023	Substantially Equivalent	Olympus Winter & Ibe GmbH
K163185	OptiLux LED Illuminator	Nov 21, 2016	Substantially Equivalent	Isolux, LLC
K141781	KOGENT SPETZLER LIGHTED SUCTION TUBES	Apr 09, 2015	Substantially Equivalent	Katalyst Surgical, LLC
K111342	LIGHT GUIDE CABLE	Nov 25, 2011	Substantially Equivalent	Schott North America
K052979	1125 XSB XENON FIBER-OPTIC LIGHT SOURCE	Oct 31, 2005	Substantially Equivalent	Isolux, LLC
K021931	ENDOSCOPIC FIBEROPTIC CABLE	Sep 06, 2002	Substantially Equivalent	Gulf Medical Fiberoptics
K991208	ENDOSCOPIC FIBEROPTIC CABLE	Jun 23, 1999	Substantially Equivalent	Isolux America
K983277	LIGHTSOURCE OR ILLUMINATOR MODEL I-100	Dec 16, 1998	Substantially Equivalent	Cuda Products Co.
K933593	LUMINOUS 150 FIBEROPTIC ILLUMINATOR	Oct 28, 1993	Substantially Equivalent	Progressive Dynamics, Inc.
K922837	S1500 XENON LIGHT SOURCE	Nov 03, 1992	Substantially Equivalent	Endomedix
K922462	NEXTEC FIBEROPTIC CABLES	Sep 21, 1992	Substantially Equivalent	Nextec Corp.
K921866	LUMINOUS 250 FIBEROPTIC ILLUMINATOR	Jul 08, 1992	Substantially Equivalent	Progressive Dynamics, Inc.
K920167	NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KEL	Mar 23, 1992	Substantially Equivalent	Nextec Corp.
K904616	STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR	Apr 19, 1991	Substantially Equivalent	Storz Instrument Co.
K904681	VLS 5300 300W XENON LIGHT SOURCE	Dec 18, 1990	Substantially Equivalent	Vistek Corp.
K904609	XENON LIGHT SOURCE	Dec 18, 1990	Substantially Equivalent	Medical Dynamics, Inc.
K901108	FIBERLUME	Mar 28, 1990	Substantially Equivalent	Burton
K896549	STORZ FIBEROPTIC ENDO-ILLUMINATORS	Feb 15, 1990	Substantially Equivalent	Storz Instrument Co.
K890398	RYAN-STYLE DIRECTED INFUSION MANIPULATOR	Feb 17, 1989	Substantially Equivalent	Advanced Surgical Products, Inc.
K883858	FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE	Sep 29, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K883857	FIBEROPTIC WIRE PICK LIGHTPIPE	Sep 29, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K883856	FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE	Sep 29, 1988	Substantially Equivalent	Advanced Surgical Products, Inc.
K883201	VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS	Sep 26, 1988	Substantially Equivalent	Vital Metrics, Inc.
K882956	VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION	Aug 03, 1988	Substantially Equivalent	Vital Metrics, Inc.
K854587	STORZ MVS DISPOSABLE FIBEROPTIC LIGHTPIPE	Feb 04, 1986	Substantially Equivalent	Storz Instrument Co.
K853948	MINNESOTA SCIENTIFIC, INC. OMNI-BEAM	Oct 16, 1985	Substantially Equivalent	Minnesota Scientific, Inc.
K810300	FIBER OPTIC ADAPTERS#60-0893	Feb 27, 1981	Substantially Equivalent	Aspen Laboratories, Inc.
K810299	FIBER OPTIC ADAPTERS#60-0891	Feb 27, 1981	Substantially Equivalent	Aspen Laboratories, Inc.