Cleared Traditional

K260413 - Levo Gen 2 Tinnitus Therapy System

K260413 is an FDA 510(k) clearance for Levo Gen 2 Tinnitus Therapy System, manufactured by Levo Medical Corporation. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K260413 · Levo Medical Corporation · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
185d
Days
Class 2
Risk

K260413 is an FDA 510(k) clearance for the Levo Gen 2 Tinnitus Therapy System. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Levo Medical Corporation (Victoria, Bc, CA). The FDA issued a Cleared decision on August 13, 2026 after a review of 185 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Levo Medical Corporation devices

FDA 510(k) Submission Details - K260413

510(k) Number K260413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2026
Decision Date August 13, 2026
Days to Decision 185 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 90d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

SpringRA, Inc.
Tal Bersler Stramer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLW Masker, Tinnitus

All 63
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K260413.
Tinnitus Therapy
K260614 · Sivantos GmbH · Jun 2026
Peace N Quiet (0.7.0)
K233435 · Pnq Health · Feb 2024
Tinearity G1 (6103)
K223694 · Duearity AB · Jun 2023
Tinnitogram Signal Generator
K221168 · Goldenear Company, Inc. · Feb 2023
SilentCloud
K221125 · Aureliym GmbH · Jan 2023
Multiflex Tinnitus Technology
K201370 · Starkey Laboratories, Inc. · Jun 2020