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510(k) K260413

Levo Gen 2 Tinnitus Therapy System by Levo Medical Corporation — Product Code KLW

K260413 is an FDA 510(k) premarket notification submitted by Levo Medical Corporation for the device "Levo Gen 2 Tinnitus Therapy System". The FDA issued a decision of Substantially Equivalent on August 13, 2026. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2026
Date Received
February 9, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

Other clearances for product code KLW

  • K260614 — Tinnitus Therapy (June 10, 2026)
  • K233435 — Peace N Quiet (0.7.0) (February 27, 2024)
  • K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (June 30, 2023)
  • K221168 — Tinnitogram Signal Generator (February 1, 2023)
  • K221125 — SilentCloud (January 4, 2023)
  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)

FDA data resources