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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 / March 2026 / K254079

510(k) cleared

LED Light Therapy Mask (Models: T2, RLD10)

Shenzhen Desida Technology Co., Ltd. · Mar 16, 2026 · K254079

FDA cleared the LED Light Therapy Mask (Models: T2, RLD10) from Shenzhen Desida Technology Co., Ltd. on Mar 16, 2026 under K254079, 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 Dec 18, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Desida Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254079?

K254079 is the FDA 510(k) for LED Light Therapy Mask (Models: T2, RLD10), submitted by Shenzhen Desida Technology Co., Ltd.. FDA's decision date was Mar 16, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Mask (Models: T2, RLD10)?

Shenzhen Desida Technology Co., Ltd., based in Shenzhen, is the applicant of record for K254079.

How long did the K254079 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on Mar 16, 2026, 88 days later.

← All decisions in March 2026