Tomey Cornea/Anterior Segment OCT (CASIA2)— 510(k) K250553

Name: FDA 510(k) clearance K250553
Creator: U.S. Food and Drug Administration
Published: 2025-07-18

Substantially Equivalent

Tomey Corporation

FDA 510(k) clearance K250553 for Tomey Cornea/Anterior Segment OCT (CASIA2), Substantially Equivalent on 2025-07-18. Applicant: Tomey Corporation. Device class: 2.

Clearance details

Applicant: Tomey Corporation
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2025-02-25
Decision date: 2025-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBO

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K261019 — ANTERION2026-09-11
K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module2026-05-07
K252633 — UNITY DX (UDX)2025-12-23
K250868 — SPECTRALIS HRA+OCT and variants2025-05-12
K240924 — Anterion2024-12-13

More clearances from Tomey Corporation

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K252348 — Tomey Optical Biometer OA-2000 (OA-2000)2025-12-18
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K171313 — EM-4000 Specular Microscope2018-01-19
K073087 — NON-CONTACT TONOMETER, MODEL FT-10002008-11-18

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