Hushd Pro Avera

FDA 510(k) K232025 · Good Sleep CO Pte , Ltd.

Substantially Equivalent

510(k) numberK232025

Submission

Device name
Hushd Pro Avera
Applicant
Good Sleep CO Pte , Ltd.
Singapore, SG
Received
July 7, 2023
Decision date
May 9, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LRK – Device, Anti-Snoring
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Specialty
Dental

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More from QuietLab, LLC

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K252161Hushd AveraLRK · Abbreviated 11/25/2025SE
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Questions and answers

When was Hushd Pro Avera cleared by the FDA?

Hushd Pro Avera (K232025) received a 510(k) decision of Substantially Equivalent on May 9, 2024, 307 days after the submission was received.

What is the product code of K232025?

The FDA product code is LRK – Device, Anti-Snoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.