Cleared Special

K092470 - OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K092470 · Topcon Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
21d
Days
Class 2
Risk

K092470 is an FDA 510(k) clearance for the OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Topcon Corp. (Tokyo, JP). The FDA issued a Cleared decision on September 2, 2009 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Topcon Corp. devices

Submission Details

510(k) Number K092470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2009
Decision Date September 02, 2009
Days to Decision 21 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OBO Tomography, Optical Coherence

All 65
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K092470.
SPECTRALIS HRA+OCT and variants
K253837 · Heidelberg Engineering GmbH · May 2026
UNITY DX (UDX)
K252633 · Cylite Pty. , Ltd. · Dec 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · Tomey Corporation · Jul 2025
SPECTRALIS HRA+OCT and variants
K250868 · Heidelberg Engineering GmbH · May 2025
Anterion
K240924 · Heidelberg Engineering GmbH · Dec 2024
SPECTRALIS with Flex Module
K241163 · Heidelberg Engineering GmbH · Oct 2024