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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 / January 2026 / K251254

510(k) cleared

Ignite RF System

InMode , Ltd. · Jan 15, 2026 · K251254

FDA cleared the Ignite RF System from InMode , Ltd. on Jan 15, 2026 under K251254, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 23, 2025. The decision came 267 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 InMode , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251254?

K251254 is the FDA 510(k) for Ignite RF System, submitted by InMode , Ltd.. FDA's decision date was Jan 15, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Ignite RF System?

InMode , Ltd., based in Yokneam Illit, is the applicant of record for K251254.

How long did the K251254 review take?

FDA received the submission on Apr 23, 2025 and issued its decision on Jan 15, 2026, 267 days later.

← All decisions in January 2026