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FDA 510(k)

Tomey Cornea/Anterior Segment OCT (CASIA2)

K-Number: K250553 · 2025-07-18

ApplicantTomey Corporation
Decision Date2025-07-18
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tomey Cornea/Anterior Segment OCT (CASIA2) is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K250553. 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 2025-07-18. The listed applicant is Tomey Corporation. The 510(k) number is K250553.

When did Tomey Cornea/Anterior Segment OCT (CASIA2) receive FDA 510(k) clearance?

Tomey Cornea/Anterior Segment OCT (CASIA2) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K250553.

Who is the listed applicant for Tomey Cornea/Anterior Segment OCT (CASIA2)?

The FDA 510(k) record lists Tomey Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07741370Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens DiseasesACTIVE_NOT_RECRUITINGNCT07751484Intalight Reference Database Protocol for VG200DRECRUITING

Other records listing Tomey Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252348Tomey Optical Biometer OA-2000 (OA-2000)K213265Tomey Cornea/Anterior Segment OCT CASIA2K171313EM-4000 Specular Microscope

Related Devices (Code: OBO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbHK241163SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemTopcon Corporation

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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