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Vantage Indirect Ophthalmoscope

by Keeler Instruments, Inc.

510(k) K060822

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK060822 Date23 May 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
HLI
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Vantage Indirect Ophthalmoscope is a binocular, indirect ophthalmic examination device designed for visualising the retina and surrounding ocular structures. It employs high-contrast optics and a neutral LED or xenon light source to provide detailed retinal imaging, facilitating comprehensive ophthalmic assessments.

This device is intended for use in clinical settings by trained ophthalmologists or optometrists. Supplied as a reusable instrument, it requires no sterilisation between uses. The device is classified as Class II under FDA regulations (K060822) and is authorised via a Special 510(k) clearance. Multiple model variants are listed under registration numbers including 3009685433 and others, adhering to regulation 886.1570.

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