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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 / April 2026 / K260307

510(k) cleared

Diode Laser Therapy Systems (V19)

Weifang Mingliang Electronics Co., Ltd. · Apr 15, 2026 · K260307

FDA cleared the Diode Laser Therapy Systems (V19) from Weifang Mingliang Electronics Co., Ltd. on Apr 15, 2026 under K260307, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 30, 2026. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Weifang Mingliang Electronics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260307?

K260307 is the FDA 510(k) for Diode Laser Therapy Systems (V19), submitted by Weifang Mingliang Electronics Co., Ltd.. FDA's decision date was Apr 15, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Therapy Systems (V19)?

Weifang Mingliang Electronics Co., Ltd., based in Shan Dong, is the applicant of record for K260307.

How long did the K260307 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Apr 15, 2026, 75 days later.

← All decisions in April 2026