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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 / November 2025 / K252642

510(k) cleared

Microcurrent Facial Device (CEC101, EEI101)

Shenzhen Dachi Communication Co., Ltd. · Nov 19, 2025 · K252642

FDA cleared the Microcurrent Facial Device (CEC101, EEI101) from Shenzhen Dachi Communication Co., Ltd. on Nov 19, 2025 under K252642, 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 Aug 21, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Dachi Communication Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252642?

K252642 is the FDA 510(k) for Microcurrent Facial Device (CEC101, EEI101), submitted by Shenzhen Dachi Communication Co., Ltd.. FDA's decision date was Nov 19, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Microcurrent Facial Device (CEC101, EEI101)?

Shenzhen Dachi Communication Co., Ltd., based in Shenzhen, is the applicant of record for K252642.

How long did the K252642 review take?

FDA received the submission on Aug 21, 2025 and issued its decision on Nov 19, 2025, 90 days later.

← All decisions in November 2025