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510(k) K111293

SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM by Soundcure, Inc. — Product Code KLW

K111293 is an FDA 510(k) premarket notification submitted by Soundcure, Inc. for the device "SOUNDCURE SERENADE TINNITUS TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 24, 2011. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Soundcure, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2011
Date Received
May 6, 2011
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 by Soundcure, Inc.

  • K150065 — SoundCure Serenade Tinnitus Treatment System (April 13, 2015)

Other clearances for product code KLW

  • K260413 — Levo Gen 2 Tinnitus Therapy System (August 13, 2026)
  • 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)

FDA data resources