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3D OCT-1000 MARK II Optical Coherence Tomography System

by Topcon Medical Systems, Inc.

510(k) K083316

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 NumberK083316 Date13 Mar 2009ClearedStatusActive

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  • Withdrawn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
OBO
Device Class
Class II
Regulation
21 CFR Part 886.1570
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 3D OCT-1000 MARK II Optical Coherence Tomography System is a non-contact ophthalmic imaging system designed for the viewing and axial cross-sectional imaging of posterior ocular structures. It combines optical coherence tomography technology with a fundus camera to provide detailed retinal imaging.

The device is supplied as a reusable system intended for use in clinical ophthalmic settings. It is classified as a Class II medical device under FDA regulation number 886.1570 and received traditional 510(k) clearance (K083316) on March 13, 2009, based on substantial equivalence to a predicate device.

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Questions

AI-generated answers, 21 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 3D OCT-1000 MARK II used for?

    The 3D OCT-1000 MARK II is used for non-contact ophthalmic imaging, specifically for viewing and axial cross-sectional imaging of posterior ocular structures.

  • Is the 3D OCT-1000 MARK II a reusable system?

    Yes, the 3D OCT-1000 MARK II is supplied as a reusable system intended for use in clinical ophthalmic settings.

  • What type of clearance did the 3D OCT-1000 MARK II receive?

    The 3D OCT-1000 MARK II received traditional 510(k) clearance (K083316) on March 13, 2009, based on substantial equivalence to a predicate device.

  • What class of medical device is the 3D OCT-1000 MARK II?

    The 3D OCT-1000 MARK II is classified as a Class II medical device under FDA regulation number 886.1570.