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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 / December 2025 / K253400

510(k) cleared

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

Shenzhen Saidi Light Therapy Technology Co., Ltd. · Dec 24, 2025 · K253400

FDA cleared the LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) from Shenzhen Saidi Light Therapy Technology Co., Ltd. on Dec 24, 2025 under K253400, 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 Sep 30, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253400?

K253400 is the FDA 510(k) for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W), submitted by Shenzhen Saidi Light Therapy Technology Co., Ltd.. FDA's decision date was Dec 24, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

Shenzhen Saidi Light Therapy Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253400.

How long did the K253400 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 24, 2025, 85 days later.

← All decisions in December 2025