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Miller/Nadler Glare Tester

by Titmus Optical, Inc.

510(k) K832762

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK832762 Date29 Sep 1983ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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
HLX
Device Class
Class II
Regulation
21 CFR Part 886.1630
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Miller/Nadler Glare Tester is an AC-powered photostimulator designed for ophthalmic use. It functions as a clinical instrument to evaluate visual acuity in the presence of glare, particularly for patients with cataracts or posterior capsule opacification.

This device is identified by product code HLX and is regulated under 21 CFR 886.1630 as a Class 2 medical device. It received FDA 510(k) clearance on September 29, 1983, under K832762. The device is manufactured by Titmus Optical, Inc.

Other devices from Titmus Optical, Inc.

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the primary clinical use of the Miller/Nadler Glare Tester?

    This device is a clinical instrument designed to assess a patient's visual acuity while they are exposed to glare. It is specifically used to evaluate visual function in patients who have cataracts or posterior capsule opacification.

  • How is the Miller/Nadler Glare Tester powered?

    The device is an AC-powered photostimulator, meaning it requires a standard alternating current electrical connection to function during ophthalmic examinations.

  • What is the regulatory status of this device?

    The Miller/Nadler Glare Tester is classified as a Class 2 medical device under 21 CFR 886.1630. It received FDA 510(k) clearance on September 29, 1983, under submission number K832762.