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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K253039

510(k) cleared

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

Topcon Corporation · Nov 7, 2025 · K253039

FDA cleared the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA from Topcon Corporation on Nov 7, 2025 under K253039, a traditional 510(k). The device falls under product code HKX, Tonometer, Ac-Powered, regulated at 21 CFR 886.1930 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Sep 22, 2025. The decision came 46 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Topcon Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253039?

K253039 is the FDA 510(k) for AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, submitted by Topcon Corporation. FDA's decision date was Nov 7, 2025, under product code HKX (Tonometer, Ac-Powered).

Who makes the AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA?

Topcon Corporation, based in Tokyo, is the applicant of record for K253039.

How long did the K253039 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Nov 7, 2025, 46 days later.

← All decisions in November 2025