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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Lumenis Be, Ltd. has one other decision in the tracker over the last 12 months: K241973 (SmartIPL_NI System).

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

Sources