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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 / June 2026 / K253893

510(k) cleared

Harmony Referral System with Harmony OCT Viewer (Octave)

Topcon Healthcare Solutions EMEA Oy · Jun 4, 2026 · K253893

FDA cleared the Harmony Referral System with Harmony OCT Viewer (Octave) from Topcon Healthcare Solutions EMEA Oy on Jun 4, 2026 under K253893, a traditional 510(k). The device falls under product code NFJ, System, Image Management, Ophthalmic, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 4, 2025. The decision came 182 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Topcon Healthcare Solutions EMEA Oy in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253893?

K253893 is the FDA 510(k) for Harmony Referral System with Harmony OCT Viewer (Octave), submitted by Topcon Healthcare Solutions EMEA Oy. FDA's decision date was Jun 4, 2026, under product code NFJ (System, Image Management, Ophthalmic).

Who makes the Harmony Referral System with Harmony OCT Viewer (Octave)?

Topcon Healthcare Solutions EMEA Oy, based in Oulu, is the applicant of record for K253893.

How long did the K253893 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Jun 4, 2026, 182 days later.

← All decisions in June 2026