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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 / March 2026 / K253834

510(k) cleared

VISUREF 600

Carl Zeiss Vision GmbH · Mar 18, 2026 · K253834

FDA cleared the VISUREF 600 from Carl Zeiss Vision GmbH on Mar 18, 2026 under K253834, a traditional 510(k). The device falls under product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered, regulated at 21 CFR 886.1850 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Dec 1, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carl Zeiss Vision GmbH has one other decision in the tracker over the last 12 months: K260694 (ZEISS CLINIC 360).

Questions & Answers

What did FDA clear under K253834?

K253834 is the FDA 510(k) for VISUREF 600, submitted by Carl Zeiss Vision GmbH. FDA's decision date was Mar 18, 2026, under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered).

Who makes the VISUREF 600?

Carl Zeiss Vision GmbH, based in Aalen, is the applicant of record for K253834.

How long did the K253834 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Mar 18, 2026, 107 days later.

← All decisions in March 2026

Sources