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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 / September 2025 / K252189

510(k) cleared

LED Light Therapy Mask (2311, 2344, 2457, 2458)

Dongguan Yanxi Technology Co., Ltd. · Sep 12, 2025 · K252189

FDA cleared the LED Light Therapy Mask (2311, 2344, 2457, 2458) from Dongguan Yanxi Technology Co., Ltd. on Sep 12, 2025 under K252189, 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 Jul 14, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K252189?

K252189 is the FDA 510(k) for LED Light Therapy Mask (2311, 2344, 2457, 2458), submitted by Dongguan Yanxi Technology Co., Ltd.. FDA's decision date was Sep 12, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Mask (2311, 2344, 2457, 2458)?

Dongguan Yanxi Technology Co., Ltd., based in Dongguan, is the applicant of record for K252189.

How long did the K252189 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Sep 12, 2025, 60 days later.

← All decisions in September 2025