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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 / K253829

510(k) cleared

Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)

Beijing HuaCheng Taike Technology Co., Ltd. · Feb 27, 2026 · K253829

FDA cleared the Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) from Beijing HuaCheng Taike Technology Co., Ltd. on Feb 27, 2026 under K253829, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, 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 1, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Beijing HuaCheng Taike Technology Co., Ltd. has one other decision in the tracker over the last 12 months: K253828 (Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)).

Questions & Answers

What did FDA clear under K253829?

K253829 is the FDA 510(k) for Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532), submitted by Beijing HuaCheng Taike Technology Co., Ltd.. FDA's decision date was Feb 27, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)?

Beijing HuaCheng Taike Technology Co., Ltd., based in Beijing, is the applicant of record for K253829.

How long did the K253829 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Feb 27, 2026, 88 days later.

← All decisions in February 2026

Sources