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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 / February 2026 / K254007

510(k) cleared

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

SZ KKS Silicone&Electronic Co., Ltd. · Feb 12, 2026 · K254007

FDA cleared the LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) from SZ KKS Silicone&Electronic Co., Ltd. on Feb 12, 2026 under K254007, 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 15, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for SZ KKS Silicone&Electronic Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254007?

K254007 is the FDA 510(k) for LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281), submitted by SZ KKS Silicone&Electronic Co., Ltd.. FDA's decision date was Feb 12, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)?

SZ KKS Silicone&Electronic Co., Ltd., based in Shenzhen, is the applicant of record for K254007.

How long did the K254007 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Feb 12, 2026, 59 days later.

← All decisions in February 2026