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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 / K253803

510(k) cleared

MILAN System

Lumenis Be, Ltd. · Jun 2, 2026 · K253803

FDA cleared the MILAN System from Lumenis Be, Ltd. on Jun 2, 2026 under K253803, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 28, 2025. The decision came 186 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 Lumenis Be, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253803?

K253803 is the FDA 510(k) for MILAN System, submitted by Lumenis Be, Ltd.. FDA's decision date was Jun 2, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the MILAN System?

Lumenis Be, Ltd., based in Yokneam Ilit, is the applicant of record for K253803.

How long did the K253803 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Jun 2, 2026, 186 days later.

← All decisions in June 2026