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 a medical device manufactured by Topcon Corporation. It received FDA 510(k) clearance on 2025-11-07 under approval 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. It is manufactured by Topcon Corporation. The 510(k) number is K253039.
When was AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA approved by the FDA?
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA received FDA 510(k) clearance on 2025-11-07, under approval number K253039.
What company makes AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA is manufactured by Topcon Corporation.
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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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.