FDA 510(k)

Levo Gen 2 Tinnitus Therapy System

Número K: K260413 · 2026-08-13

Data da decisão2026-08-13

Código do produtoKLW

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Levo Gen 2 Tinnitus Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Levo Medical Corporation. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K260413. The device is classified under product code KLW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Levo Gen 2 Tinnitus Therapy System?

Levo Gen 2 Tinnitus Therapy System is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Levo Medical Corporation. The 510(k) number is K260413.

When did Levo Gen 2 Tinnitus Therapy System receive FDA 510(k) clearance?

Levo Gen 2 Tinnitus Therapy System received FDA 510(k) clearance on 2026-08-13, under 510(k) number K260413.

Who is the listed applicant for Levo Gen 2 Tinnitus Therapy System?

The FDA 510(k) record lists Levo Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Levo Gen 2 Tinnitus Therapy System?

The FDA product code for Levo Gen 2 Tinnitus Therapy System is KLW.

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Dispositivos Relacionados (Código: KLW)

K260614Tinnitus TherapySivantos GmbH K233435Peace N Quiet (0.7.0)Pnq Health K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)Duearity AB K221168Tinnitogram Signal GeneratorGoldenear Company, Inc.K221125SilentCloudAureliym GmbH K201370Multiflex Tinnitus TechnologyStarkey Laboratories, Inc.

Fonte oficial

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