Tomey Cornea/Anterior Segment OCT CASIA2— 510(k) K213265

Name: FDA 510(k) clearance K213265
Creator: U.S. Food and Drug Administration
Published: 2022-04-27

Substantially Equivalent

Tomey Corporation

FDA 510(k) clearance K213265 for Tomey Cornea/Anterior Segment OCT CASIA2, Substantially Equivalent on 2022-04-27. 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: 2021-09-30
Decision date: 2022-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nishi-Ku, JP

Download summary PDF View on FDA.gov ↗

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K253837 — SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module2026-05-07
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K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2)2025-07-18
K250868 — SPECTRALIS HRA+OCT and variants2025-05-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.