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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 / K261601

510(k) cleared

LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)

Shenzhen Chuangtong Yigou Technology Co., Ltd. · Aug 7, 2026 · K261601

FDA cleared the LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08) from Shenzhen Chuangtong Yigou Technology Co., Ltd. on Aug 7, 2026 under K261601, 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 14, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Chuangtong Yigou Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K254047 (Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)).

Questions & Answers

What did FDA clear under K261601?

K261601 is the FDA 510(k) for LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08), submitted by Shenzhen Chuangtong Yigou Technology Co., Ltd.. FDA's decision date was Aug 7, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)?

Shenzhen Chuangtong Yigou Technology Co., Ltd., based in Shenzhen, is the applicant of record for K261601.

How long did the K261601 review take?

FDA received the submission on May 14, 2026 and issued its decision on Aug 7, 2026, 85 days later.

← All decisions in August 2026

Sources