Cleared Traditional

QuietLab Pro

K253868 · QuietLab, LLC · Dental

Dec 2025

Decision

Days

Class 2

Risk

About This 510(k) Submission

K253868 is an FDA 510(k) clearance for the QuietLab Pro, a Device, Anti-snoring (Class II — Special Controls, product code LRK), submitted by QuietLab, LLC (New York, US). The FDA issued a Cleared decision on December 5, 2025, 2 days after receiving the submission on December 3, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K253868 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2025
Decision Date	December 05, 2025
Days to Decision	2 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF