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FDA 510(k)

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

K-Number: K253039 · 2025-11-07

ApplicantTopcon Corporation
Decision Date2025-11-07
Product CodeHKX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K253039. The device is classified under product code HKX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Topcon Corporation. The 510(k) number is K253039.

When did AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA receive FDA 510(k) clearance?

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA received FDA 510(k) clearance on 2025-11-07, under 510(k) number K253039.

Who is the listed applicant for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

The FDA 510(k) record lists Topcon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

The FDA product code for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is HKX.

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Related Devices (Code: HKX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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