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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 / K254047

510(k) cleared

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)

Shenzhen Chuangtong Yigou Technology Co., Ltd. · Mar 11, 2026 · K254047

FDA cleared the 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) from Shenzhen Chuangtong Yigou Technology Co., Ltd. on Mar 11, 2026 under K254047, a traditional 510(k). The device falls under product code OHT, Light Based Over-The-Counter Hair Removal, 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 17, 2025. The decision came 84 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: K261601 (LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)).

Questions & Answers

What did FDA clear under K254047?

K254047 is the FDA 510(k) for 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), submitted by Shenzhen Chuangtong Yigou Technology Co., Ltd.. FDA's decision date was Mar 11, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the 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)?

Shenzhen Chuangtong Yigou Technology Co., Ltd., based in Shenzhen, is the applicant of record for K254047.

How long did the K254047 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Mar 11, 2026, 84 days later.

← All decisions in March 2026

Sources