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THE TAPE

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 / February 2026 / K252599

510(k) cleared

Diode Laser Therapy Systems (WLA-02)

Wingderm Electro-Optics , Ltd. · Feb 24, 2026 · K252599

FDA cleared the Diode Laser Therapy Systems (WLA-02) from Wingderm Electro-Optics , Ltd. on Feb 24, 2026 under K252599, 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 Aug 18, 2025. The decision came 190 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 Wingderm Electro-Optics , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252599?

K252599 is the FDA 510(k) for Diode Laser Therapy Systems (WLA-02), submitted by Wingderm Electro-Optics , Ltd.. FDA's decision date was Feb 24, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Therapy Systems (WLA-02)?

Wingderm Electro-Optics , Ltd., based in Beijing, is the applicant of record for K252599.

How long did the K252599 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Feb 24, 2026, 190 days later.

← All decisions in February 2026