Tomey Optical Biometer OA-2000 (OA-2000)— 510(k) K252348

Name: FDA 510(k) clearance K252348
Creator: U.S. Food and Drug Administration
Published: 2025-12-18

Substantially Equivalent

Tomey Corporation

FDA 510(k) clearance K252348 for Tomey Optical Biometer OA-2000 (OA-2000), Substantially Equivalent on 2025-12-18. Applicant: Tomey Corporation. Device class: 2.

Clearance details

Applicant: Tomey Corporation
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2025-07-29
Decision date: 2025-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nagoya, JP

Download summary PDF View on FDA.gov ↗

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