Cleared Traditional

Tomey Cornea/Anterior Segment OCT (CASIA2)

K250553 · Tomey Corporation · Ophthalmic

Jul 2025

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K250553 is an FDA 510(k) clearance for the Tomey Cornea/Anterior Segment OCT (CASIA2), a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on July 18, 2025, 143 days after receiving the submission on February 25, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K250553 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2025
Decision Date	July 18, 2025
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — 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.