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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 / October 2025 / K252447

510(k) cleared

Picosecond laser device (BMPS4)

Hebei Newangie Technology Co., Ltd. · Oct 1, 2025 · K252447

FDA cleared the Picosecond laser device (BMPS4) from Hebei Newangie Technology Co., Ltd. on Oct 1, 2025 under K252447, 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 Aug 4, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hebei Newangie Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252447?

K252447 is the FDA 510(k) for Picosecond laser device (BMPS4), submitted by Hebei Newangie Technology Co., Ltd.. FDA's decision date was Oct 1, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Picosecond laser device (BMPS4)?

Hebei Newangie Technology Co., Ltd., based in Shijiazhuang City, is the applicant of record for K252447.

How long did the K252447 review take?

FDA received the submission on Aug 4, 2025 and issued its decision on Oct 1, 2025, 58 days later.

← All decisions in October 2025