Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Tomey Corporation. It received FDA 510(k) clearance on 2025-07-18 under approval 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. It is manufactured by Tomey Corporation. The 510(k) number is K250553.

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

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

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.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07566598 Measuring Absolute Brain Flow and Brain Microcirculation Resistance by Continuous Thermodilution RECRUITING NCT07521267 Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch RECRUITING NCT07495345 Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001) COMPLETED

Other Devices by Tomey Corporation

K171313EM-4000 Specular Microscope K213265Tomey Cornea/Anterior Segment OCT CASIA2 K252348Tomey Optical Biometer OA-2000 (OA-2000)

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.

↑