3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

FDA 510(k) K231222 · Topcon Corporation

Substantially Equivalent

510(k) numberK231222

Submission

Device name
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Applicant
Topcon Corporation
Itabashi-Ku, JP
Received
April 28, 2023
Decision date
October 30, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBO – Tomography, Optical Coherence
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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K261019AnterionOBO · Traditional Heidelberg Engineering GmbH09/11/2026SE
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K252633Unity DX (Udx)OBO · Traditional Cylite Pty. , Ltd.12/23/2025SE
K250553Tomey Cornea/Anterior Segment OCT (CASIA2)OBO · Traditional Tomey Corporation07/18/2025SE
K250868SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH05/12/2025SE
K240924AnterionOBO · Traditional Heidelberg Engineering GmbH12/13/2024SE
K241163SPECTRALIS with Flex ModuleOBO · Traditional Heidelberg Engineering GmbH10/11/2024SE
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional Topcon Corporation07/17/2024SE
K240221SPECTRALIS HRA+OCT and variantsOBO · Traditional Heidelberg Engineering GmbH07/01/2024SE
K233933CIRRUS™ HD-OCT Model 6000OBO · Traditional Carl Zeiss Meditec, Inc.05/17/2024SE

More from Carl Zeiss Meditec, Inc.

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K253039Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional 11/07/2025SE
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional 07/17/2024SE
K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))OBO · Traditional 04/10/2024SE
K232828IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional 03/01/2024SE
K221111Non-Mydriatic Retinal Camera NW500HKI · Traditional 08/29/2022SE
K173119DRI OCT TritonOBO · Traditional 01/19/2018SE
K171370IMAGEnet 6 Ophthalmic Data SystemNFJ · Traditional 11/01/2017SE
K1701643D OCT-1 MaestroOBO · Special 03/03/2017SE
K161972Slit Lamp SL-D301HJO · Traditional 12/09/2016SE
K1615093D OCT-1 MaestroOBO · Traditional 07/28/2016SE

Questions and answers

When was 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) cleared by the FDA?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222) received a 510(k) decision of Substantially Equivalent on October 30, 2023, 185 days after the submission was received.

What is the product code of K231222?

The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.