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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 / K252319

510(k) cleared

Q-Switched Nd: YAG Laser machine (LFS-C13U)

Sanhe Lefis Electronics Co., Ltd. · Oct 20, 2025 · K252319

FDA cleared the Q-Switched Nd: YAG Laser machine (LFS-C13U) from Sanhe Lefis Electronics Co., Ltd. on Oct 20, 2025 under K252319, 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 Jul 25, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Sanhe Lefis Electronics Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261204 (Intense Pulsed Light Therapy Device), K250998 (CO2 Laser Therapy System (Model: LFS-D9U)).

Questions & Answers

What did FDA clear under K252319?

K252319 is the FDA 510(k) for Q-Switched Nd: YAG Laser machine (LFS-C13U), submitted by Sanhe Lefis Electronics Co., Ltd.. FDA's decision date was Oct 20, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Q-Switched Nd: YAG Laser machine (LFS-C13U)?

Sanhe Lefis Electronics Co., Ltd., based in Langfang, is the applicant of record for K252319.

How long did the K252319 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Oct 20, 2025, 87 days later.

← All decisions in October 2025

Sources