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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 / K261496

510(k) cleared

LED Light Therapy Masks (PE748, PE749, PE756)

Duplex International Trading Limited · Aug 4, 2026 · K261496

FDA cleared the LED Light Therapy Masks (PE748, PE749, PE756) from Duplex International Trading Limited on Aug 4, 2026 under K261496, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, 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 May 6, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Duplex International Trading Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261496?

K261496 is the FDA 510(k) for LED Light Therapy Masks (PE748, PE749, PE756), submitted by Duplex International Trading Limited. FDA's decision date was Aug 4, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Masks (PE748, PE749, PE756)?

Duplex International Trading Limited, based in Hongkong, is the applicant of record for K261496.

How long did the K261496 review take?

FDA received the submission on May 6, 2026 and issued its decision on Aug 4, 2026, 90 days later.

← All decisions in August 2026