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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 / K260885

510(k) cleared

VERAFEYE Imaging and Guidance System (VF-VIS-002)

Luma Vision Limited · Jun 15, 2026 · K260885

FDA cleared the VERAFEYE Imaging and Guidance System (VF-VIS-002) from Luma Vision Limited on Jun 15, 2026 under K260885, a traditional 510(k). The review panel was Unknown.

FDA logged the submission as received on Mar 17, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Luma Vision Limited has one other decision in the tracker over the last 12 months: K261849 (VERAFEYE Imaging Catheter (VF-VIC-002)).

Questions & Answers

What did FDA clear under K260885?

K260885 is the FDA 510(k) for VERAFEYE Imaging and Guidance System (VF-VIS-002), submitted by Luma Vision Limited. FDA's decision date was Jun 15, 2026.

Who makes the VERAFEYE Imaging and Guidance System (VF-VIS-002)?

Luma Vision Limited, based in Dublin, is the applicant of record for K260885.

How long did the K260885 review take?

FDA received the submission on Mar 17, 2026 and issued its decision on Jun 15, 2026, 90 days later.

← All decisions in June 2026