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Nidek Digital Keratometer

by Nidek, Inc.

510(k) K842892

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK842892 Date5 Oct 1984ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HQL
Device class
Class III
Regulation
21 CFR Part 886.3600
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Nidek Digital Keratometer is a diagnostic device classified as a keratometer, used to measure the curvature of the cornea. It provides precise readings of corneal radius and refractive power, aiding in the assessment of corneal topography and the fitting of contact lenses or intraocular lenses.

This device is intended for use in ophthalmic settings and is supplied as a reusable instrument. It requires no sterility beyond standard clinical cleaning protocols and is not intended for MRI environments. The device is authorised under FDA 510(k) clearance (K842892) and falls under regulation number 886.3600. No third-party review was involved in its authorisation.

Similar devices

Other devices filed under FDA product code HQL (Intraocular Lens).

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