510(k) K253039

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA by Topcon Corporation — Product Code HKX

K253039 is an FDA 510(k) premarket notification submitted by Topcon Corporation for the device "AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA". The FDA issued a decision of Substantially Equivalent on November 7, 2025. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Topcon Corporation has at least 10 other 510(k) clearances on record.