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FDA 510(k)

Difiney Advanced Anti Snoring Device 4.0

K-Number: K253355 · 2025-10-29

Decision Date2025-10-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Difiney Advanced Anti Snoring Device 4.0 is a medical device manufactured by Fissiontech, LLC. It received FDA 510(k) clearance on 2025-10-29 under approval number K253355. 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 Difiney Advanced Anti Snoring Device 4.0?

Difiney Advanced Anti Snoring Device 4.0 is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Fissiontech, LLC. The 510(k) number is K253355.

When was Difiney Advanced Anti Snoring Device 4.0 approved by the FDA?

Difiney Advanced Anti Snoring Device 4.0 received FDA 510(k) clearance on 2025-10-29, under approval number K253355.

What company makes Difiney Advanced Anti Snoring Device 4.0?

Difiney Advanced Anti Snoring Device 4.0 is manufactured by Fissiontech, LLC.

What is the FDA product code for Difiney Advanced Anti Snoring Device 4.0?

The FDA product code for Difiney Advanced Anti Snoring Device 4.0 is LRK.

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Official Source

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