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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 / December 2025 / K250998

510(k) cleared

CO2 Laser Therapy System (Model: LFS-D9U)

Sanhe Lefis Electronics Co., Ltd. · Dec 19, 2025 · K250998

FDA cleared the CO2 Laser Therapy System (Model: LFS-D9U) from Sanhe Lefis Electronics Co., Ltd. on Dec 19, 2025 under K250998, 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 Apr 1, 2025. The decision came 262 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sanhe Lefis Electronics Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261204 (Intense Pulsed Light Therapy Device), K252319 (Q-Switched Nd: YAG Laser machine (LFS-C13U)).

Questions & Answers

What did FDA clear under K250998?

K250998 is the FDA 510(k) for CO2 Laser Therapy System (Model: LFS-D9U), submitted by Sanhe Lefis Electronics Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser Therapy System (Model: LFS-D9U)?

Sanhe Lefis Electronics Co., Ltd., based in Langfang, is the applicant of record for K250998.

How long did the K250998 review take?

FDA received the submission on Apr 1, 2025 and issued its decision on Dec 19, 2025, 262 days later.

← All decisions in December 2025

Sources