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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 / K251910

510(k) cleared

Focal One®

Edap Technomed, Inc. · Nov 19, 2025 · K251910

FDA cleared the Focal One® from Edap Technomed, Inc. on Nov 19, 2025 under K251910, a traditional 510(k). The device falls under product code PLP, High Intensity Ultrasound System For Prostate Tissue Ablation, regulated at 21 CFR 876.4340 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 20, 2025. The decision came 152 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Edap Technomed, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251910?

K251910 is the FDA 510(k) for Focal One®, submitted by Edap Technomed, Inc.. FDA's decision date was Nov 19, 2025, under product code PLP (High Intensity Ultrasound System For Prostate Tissue Ablation).

Who makes the Focal One®?

Edap Technomed, Inc., based in Austin, TX, is the applicant of record for K251910.

How long did the K251910 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Nov 19, 2025, 152 days later.

← All decisions in November 2025