Cleared Traditional

K072971 - TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS

K072971 is an FDA 510(k) clearance for TOPCON 3D OCT-1000 OPTICAL COHERENCE TO..., manufactured by Topcon Medical Systems, Inc.. The device is a Class 2 Ophthalmic device with product code OBO cleared through the Traditional 510(k) pathway after a 449-day FDA review.

K072971 · Topcon Medical Systems, Inc. · Ophthalmic device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Jan 2009

Decision

449d

Days

Class 2

Risk

K072971 is an FDA 510(k) clearance for the TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RET.... Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Topcon Medical Systems, Inc. (Washington, US). The FDA issued a Cleared decision on January 13, 2009 after a review of 449 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

FDA 510(k) Submission Details - K072971

510(k) Number	K072971 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 22, 2007
Decision Date	January 13, 2009
Days to Decision	449 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

339d slower than avg

Panel avg: 110d · This submission: 449d

Pathway characteristics

Predicate-based equivalence.

OBO Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov

NCT00792259 Completed Observational Industry-sponsored

Topcon 3D OCT-1000 Optical Coherence Tomography System

Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study

Patients (actual)

Sites

Condition studied	Retinal Disease; Glaucoma
Eligibility	All sexes · 18 Years+ · Healthy volunteers accepted
Sponsor	Topcon Medical Systems, Inc. (industry)

Started 2008-10-01 → Primary completion 2008-11-01

Primary outcome

Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device

View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 66

Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K072971.

OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

K092470 · Topcon Corp. · Sep 2009

CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000

K083291 · Carl Zeiss Meditec, Inc. · May 2009

3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM

K083316 · Topcon Medical Systems, Inc. · Mar 2009

SPECTRAL OCT/SLO

K080460 · Opko Health, Inc. · Nov 2008

SOCT COPERNICUS, MODEL 15205

K071839 · Reichert, Inc. · Feb 2008

CA, MODEL: CAM

K071250 · Optovue, Inc. · Sep 2007

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K072971

Topcon Medical Systems, Inc.

Washington, DC · US

JONATHAN S KAHAN

Regulatory profile

11 submissions 11 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Topcon Medical Systems, Inc. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 13, 2009. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

Verify on FDA.gov

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