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FDA 510(k)

Tomey Cornea/Anterior Segment OCT CASIA2

K-Number: K213265 · 2022-04-27

ApplicantTomey Corporation
Decision Date2022-04-27
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tomey Cornea/Anterior Segment OCT CASIA2 is a medical device manufactured by Tomey Corporation. It received FDA 510(k) clearance on 2022-04-27 under approval number K213265. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tomey Cornea/Anterior Segment OCT CASIA2?

Tomey Cornea/Anterior Segment OCT CASIA2 is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Tomey Corporation. The 510(k) number is K213265.

When was Tomey Cornea/Anterior Segment OCT CASIA2 approved by the FDA?

Tomey Cornea/Anterior Segment OCT CASIA2 received FDA 510(k) clearance on 2022-04-27, under approval number K213265.

What company makes Tomey Cornea/Anterior Segment OCT CASIA2?

Tomey Cornea/Anterior Segment OCT CASIA2 is manufactured by Tomey Corporation.

What is the FDA product code for Tomey Cornea/Anterior Segment OCT CASIA2?

The FDA product code for Tomey Cornea/Anterior Segment OCT CASIA2 is OBO.

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Other Devices by Tomey Corporation

K171313EM-4000 Specular Microscope K252348Tomey Optical Biometer OA-2000 (OA-2000) K250553Tomey Cornea/Anterior Segment OCT (CASIA2)

Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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