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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 / August 2026 / K260413

510(k) cleared

Levo Gen 2 Tinnitus Therapy System

Levo Medical Corporation · Aug 13, 2026 · K260413

FDA cleared the Levo Gen 2 Tinnitus Therapy System from Levo Medical Corporation on Aug 13, 2026 under K260413, a traditional 510(k). The device falls under product code KLW, Masker, Tinnitus, regulated at 21 CFR 874.3400 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Feb 9, 2026. The decision came 185 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 Levo Medical Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260413?

K260413 is the FDA 510(k) for Levo Gen 2 Tinnitus Therapy System, submitted by Levo Medical Corporation. FDA's decision date was Aug 13, 2026, under product code KLW (Masker, Tinnitus).

Who makes the Levo Gen 2 Tinnitus Therapy System?

Levo Medical Corporation, based in Victoria, Bc, is the applicant of record for K260413.

How long did the K260413 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on Aug 13, 2026, 185 days later.

← All decisions in August 2026