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FDA 510(k)

QuietLab Pro

K-Number: K253868 · 2025-12-05

ApplicantQuietLab, LLC
Decision Date2025-12-05
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QuietLab Pro is a medical device manufactured by QuietLab, LLC. It received FDA 510(k) clearance on 2025-12-05 under approval number K253868. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuietLab Pro?

QuietLab Pro is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by QuietLab, LLC. The 510(k) number is K253868.

When was QuietLab Pro approved by the FDA?

QuietLab Pro received FDA 510(k) clearance on 2025-12-05, under approval number K253868.

What company makes QuietLab Pro?

QuietLab Pro is manufactured by QuietLab, LLC.

What is the FDA product code for QuietLab Pro?

The FDA product code for QuietLab Pro is LRK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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