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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 / November 2025 / K250642

510(k) cleared

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)

Huizhou Foryou Medical Devices Co., Ltd. · Nov 19, 2025 · K250642

FDA cleared the LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) from Huizhou Foryou Medical Devices Co., Ltd. on Nov 19, 2025 under K250642, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Mar 4, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Huizhou Foryou Medical Devices Co., Ltd. has one other decision in the tracker over the last 12 months: K252028 (LUOFUCON® Antimicrobial Wound Gel).

Questions & Answers

What did FDA clear under K250642?

K250642 is the FDA 510(k) for LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.), submitted by Huizhou Foryou Medical Devices Co., Ltd.. FDA's decision date was Nov 19, 2025, under product code FRO (Dressing, Wound, Drug).

Who makes the LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)?

Huizhou Foryou Medical Devices Co., Ltd., based in Huizhou, is the applicant of record for K250642.

How long did the K250642 review take?

FDA received the submission on Mar 4, 2025 and issued its decision on Nov 19, 2025, 260 days later.

← All decisions in November 2025

Sources