Cleared Traditional

SilentCloud

K221125 · Aureliym GmbH · Ear, Nose, Throat
Jan 2023
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K221125 is an FDA 510(k) clearance for the SilentCloud, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Aureliym GmbH (Bad Neuenahr-Ahrweiler, DE). The FDA issued a Cleared decision on January 4, 2023, 261 days after receiving the submission on April 18, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number K221125 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2022
Decision Date January 04, 2023
Days to Decision 261 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KLW — Masker, Tinnitus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3400