Cleared Traditional

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

K253039 · Topcon Corporation · Ophthalmic
Nov 2025
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K253039 is an FDA 510(k) clearance for the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 7, 2025, 46 days after receiving the submission on September 22, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K253039 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date November 07, 2025
Days to Decision 46 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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