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Opto Global Digital Fundus Camera System Model ADS 1.5

by Opto Global, Inc.

510(k) K053044

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 · Traditional NumberK053044 Date24 Jan 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  • Withdrawn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
HKI
Device Class
Class II
Regulation
21 CFR Part 886.1120
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Opto Global Digital Fundus Camera System Model ADS 1.5 is an ophthalmic, AC-powered camera device intended for capturing, archiving, and displaying digital images of the eye, particularly the fundus. It is classified under regulation number 886.1120 and product code HKI, with a device classification of Class II.

The device received FDA 510(k) clearance (K053044) on January 24, 2006, following a traditional submission process. It was determined to be substantially equivalent to a predicate device and reviewed by the Ophthalmic advisory committee. The system is manufactured by Opto Global, Inc. and is intended for use in clinical settings for ophthalmic imaging.

Questions

AI-generated answers, 24 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 Opto Global Digital Fundus Camera System Model ADS 1.5 used for?

    It is intended for capturing, archiving, and displaying digital images of the eye, particularly the fundus, in clinical ophthalmic settings to support diagnostic imaging and patient record-keeping.

  • How is the Opto Global Digital Fundus Camera System Model ADS 1.5 powered and what type of device is it?

    The system is an AC-powered ophthalmic camera device, meaning it requires connection to an alternating current power source for operation and is designed specifically for eye imaging in clinical environments.

  • What regulatory pathway was used for the Opto Global Digital Fundus Camera System Model ADS 1.5 and when was it cleared?

    The device received FDA 510(k) clearance through a traditional submission process on January 24, 2006, under clearance number K053044, after being determined substantially equivalent to a predicate device.