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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 / May 2026 / K254024

510(k) cleared

MR5 Activ Pro

Multi Radiance Medical, Inc. · May 19, 2026 · K254024

FDA cleared the MR5 Activ Pro from Multi Radiance Medical, Inc. on May 19, 2026 under K254024, a traditional 510(k). The device falls under product code NHN, Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 16, 2025. The decision came 154 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 Multi Radiance Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254024?

K254024 is the FDA 510(k) for MR5 Activ Pro, submitted by Multi Radiance Medical, Inc.. FDA's decision date was May 19, 2026, under product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy).

Who makes the MR5 Activ Pro?

Multi Radiance Medical, Inc., based in Solon, OH, is the applicant of record for K254024.

How long did the K254024 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on May 19, 2026, 154 days later.

← All decisions in May 2026