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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 / June 2026 / K261204

510(k) cleared

Intense Pulsed Light Therapy Device

Sanhe LEFIS Electronics Co., Ltd. · Jun 12, 2026 · K261204

FDA cleared the Intense Pulsed Light Therapy Device from Sanhe LEFIS Electronics Co., Ltd. on Jun 12, 2026 under K261204, a traditional 510(k). The device falls under product code ONF, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 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 13, 2026. The decision came 60 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: K250998 (CO2 Laser Therapy System (Model: LFS-D9U)), K252319 (Q-Switched Nd: YAG Laser machine (LFS-C13U)).

Questions & Answers

What did FDA clear under K261204?

K261204 is the FDA 510(k) for Intense Pulsed Light Therapy Device, submitted by Sanhe LEFIS Electronics Co., Ltd.. FDA's decision date was Jun 12, 2026, under product code ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect).

Who makes the Intense Pulsed Light Therapy Device?

Sanhe LEFIS Electronics Co., Ltd., based in Langfang, is the applicant of record for K261204.

How long did the K261204 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on Jun 12, 2026, 60 days later.

← All decisions in June 2026

Sources