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Laser Flare Cell Meter FC-1000

by Kowa Optimed, Inc. 510(k)

Active United States

510(k) K880920

Overview

The Laser Flare Cell Meter FC-1000 is a biomicroscope, slit-lamp, AC-powered device used in ophthalmic applications. It is designed to measure laser flare and cell counts in the anterior chamber of the eye.

The device is supplied as a reusable instrument and requires AC power for operation. It received FDA 510(k) clearance under K880920 on September 27, 1988, and is classified as a Class II medical device with product code HJO and regulation number 886.1850.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880920 Date27 Sep 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HJO
Device Class
Class II
Regulation
21 CFR Part 886.1850
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Laser Flare Cell Meter FC-1000 used for?

    The Laser Flare Cell Meter FC-1000 is used in ophthalmic applications to measure laser flare and cell counts in the anterior chamber of the eye, aiding in the assessment of intraocular inflammation.

  • Is the Laser Flare Cell Meter FC-1000 reusable or single-use?

    The device is supplied as a reusable instrument, meaning it is designed for multiple uses after proper cleaning and maintenance between procedures.

  • What power source does the Laser Flare Cell Meter FC-1000 require?

    The Laser Flare Cell Meter FC-1000 requires AC power for operation, as it is an AC-powered device designed for consistent performance in clinical settings.