Product Code: FCT FDA class 2 21 CFR 886.4335

Headlight, Fiberoptic Focusing

Ophthalmic

The Fiberoptic Focusing Headlight (product code FCT) is a head-mounted illumination device that uses fiberoptic technology to focus a beam of light onto the surgical field, providing hands-free illumination for the surgeon. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 886.4335 in the Ophthalmic specialty. No special flags apply.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code FCT 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: FCT
Device Class: FDA class 2
Regulation Number: 886.4335
Medical Specialty: Ophthalmic
Review Panel: OP
Submission Type: 4

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 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K960767	LIGHT COMMANDER	Aug 26, 1996	Substantially Equivalent	Scieran Technologies, Inc.
K924198	MODIFIED SITE FIBER OPTIC MODULE	Nov 23, 1992	Substantially Equivalent	Chiron Vision Corp.
K883480	MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE	Aug 24, 1988	Substantially Equivalent	Site Microsurgical Systems, Inc.
K802770	FIBER OPTIC HEADLIGHT #60-0766766	Dec 11, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802769	FIBER OPTIC HEADLIGHT #60-0765	Dec 11, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K780433	FIBER OPTIC ADJUSTABLE HEADLIGHT	Jun 13, 1978	Substantially Equivalent	Cameron-Miller, Inc.