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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 / K253920

510(k) cleared

CO2 Laser Treatment Machine (CFR3M1)

Haidari Beauty Technology (Beijing) Co., Ltd. · Mar 3, 2026 · K253920

FDA cleared the CO2 Laser Treatment Machine (CFR3M1) from Haidari Beauty Technology (Beijing) Co., Ltd. on Mar 3, 2026 under K253920, 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 8, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Haidari Beauty Technology (Beijing) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253920?

K253920 is the FDA 510(k) for CO2 Laser Treatment Machine (CFR3M1), submitted by Haidari Beauty Technology (Beijing) Co., Ltd.. FDA's decision date was Mar 3, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser Treatment Machine (CFR3M1)?

Haidari Beauty Technology (Beijing) Co., Ltd., based in Village E., Heguo Town, Nanhe County,Xin, is the applicant of record for K253920.

How long did the K253920 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Mar 3, 2026, 85 days later.

← All decisions in March 2026