Cleared Traditional

Tomey Optical Biometer OA-2000 (OA-2000)

K252348 · Tomey Corporation · Ophthalmic

Dec 2025

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K252348 is an FDA 510(k) clearance for the Tomey Optical Biometer OA-2000 (OA-2000), a Device, Analysis, Anterior Segment (Class II — Special Controls, product code MXK), submitted by Tomey Corporation (Nagoya, JP). The FDA issued a Cleared decision on December 18, 2025, 142 days after receiving the submission on July 29, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K252348 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2025
Decision Date	December 18, 2025
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF