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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 / August 2026 / K253790

510(k) cleared

High Intensity Focused Electromagnetic Stimulation Device (FE60)

Beijing Winkonlaser Technology Limited · Aug 13, 2026 · K253790

FDA cleared the High Intensity Focused Electromagnetic Stimulation Device (FE60) from Beijing Winkonlaser Technology Limited on Aug 13, 2026 under K253790, a traditional 510(k). The device falls under product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning, regulated at 21 CFR 890.5850 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 28, 2025. The decision came 258 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 Beijing Winkonlaser Technology Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253790?

K253790 is the FDA 510(k) for High Intensity Focused Electromagnetic Stimulation Device (FE60), submitted by Beijing Winkonlaser Technology Limited. FDA's decision date was Aug 13, 2026, under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Who makes the High Intensity Focused Electromagnetic Stimulation Device (FE60)?

Beijing Winkonlaser Technology Limited, based in Beijing, is the applicant of record for K253790.

How long did the K253790 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Aug 13, 2026, 258 days later.

← All decisions in August 2026