Cleared Traditional

Hushd Pro Avera

K232025 · Good Sleep CO Pte , Ltd. · Dental

May 2024

Decision

307d

Days

Class 2

Risk

About This 510(k) Submission

K232025 is an FDA 510(k) clearance for the Hushd Pro Avera, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by Good Sleep CO Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 9, 2024, 307 days after receiving the submission on July 7, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K232025 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2023
Decision Date	May 09, 2024
Days to Decision	307 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF