Cleared Traditional

K253039 - AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K253039 is an FDA 510(k) clearance for the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on November 7, 2025 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Topcon Corporation devices

Submission Details

510(k) Number K253039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 110d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Orasi Consulting, LLC
Lena Sattler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.