Soundcure Serenade Tinnitus Treatment System

FDA 510(k) K111293 · Soundcure, Inc.

Substantially Equivalent

510(k) numberK111293

Submission

Device name
Soundcure Serenade Tinnitus Treatment System
Applicant
Soundcure, Inc.
San Jose, CA, US
Received
May 6, 2011
Decision date
August 24, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KLW – Masker, Tinnitus
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3400
Specialty
Ear, Nose, Throat

Other 510(k)s with product code KLW

510(k)DeviceApplicantDecision
K260413Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional Levo Medical Corporation08/13/2026SE
K260614Tinnitus TherapyKLW · Special Sivantos GmbH06/10/2026SE
K233435Peace N Quiet (0.7.0)KLW · Traditional Pnq Health02/27/2024SE
K223694Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)KLW · Traditional Duearity AB06/30/2023SE
K221168Tinnitogram Signal GeneratorKLW · Traditional Goldenear Company, Inc.02/01/2023SE
K221125SilentCloudKLW · Traditional Aureliym GmbH01/04/2023SE
K201370Multiflex Tinnitus TechnologyKLW · Special Starkey Laboratories, Inc.06/19/2020SE
K193303Tinnitus Sound Generator ModuleKLW · Special GN Hearing A/S02/20/2020SE
K180495Tinnitus Sound Generator ModuleKLW · Traditional GN Hearing A/S11/30/2018SE
K181586Tinnitus Sound Generator ModuleKLW · Special GN Hearing A/S07/13/2018SE

More from GN Hearing A/S

510(k)DeviceDecision
K150065SoundCure Serenade Tinnitus Treatment SystemKLW · Traditional 04/13/2015SE

Questions and answers

When was Soundcure Serenade Tinnitus Treatment System cleared by the FDA?

Soundcure Serenade Tinnitus Treatment System (K111293) received a 510(k) decision of Substantially Equivalent on August 24, 2011, 110 days after the submission was received.

What is the product code of K111293?

The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.