WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K250341

510(k) cleared

Sensilift Pro (ST300XXYYZZZ)

El Global Trade, Ltd. · Jan 6, 2026 · K250341

FDA cleared the Sensilift Pro (ST300XXYYZZZ) from El Global Trade, Ltd. on Jan 6, 2026 under K250341, a traditional 510(k). The device falls under product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction, regulated at 21 CFR 878.4420 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 6, 2025. The decision came 334 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

El Global Trade, Ltd. has one other decision in the tracker over the last 12 months: K252621 (DeepSkin (DEP100)).

Questions & Answers

What did FDA clear under K250341?

K250341 is the FDA 510(k) for Sensilift Pro (ST300XXYYZZZ), submitted by El Global Trade, Ltd.. FDA's decision date was Jan 6, 2026, under product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).

Who makes the Sensilift Pro (ST300XXYYZZZ)?

El Global Trade, Ltd., based in Netanya, is the applicant of record for K250341.

How long did the K250341 review take?

FDA received the submission on Feb 6, 2025 and issued its decision on Jan 6, 2026, 334 days later.

← All decisions in January 2026

Sources