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FDA 510(k)

Difiney Advanced Anti Snoring Device 4.0

K-Number: K253355 · 2025-10-29

ApplicantFissiontech, LLC
Decision Date2025-10-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Difiney Advanced Anti Snoring Device 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Fissiontech, LLC. It received FDA 510(k) clearance on 2025-10-29 under 510(k) 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. The listed applicant is Fissiontech, LLC. The 510(k) number is K253355.

When did Difiney Advanced Anti Snoring Device 4.0 receive FDA 510(k) clearance?

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

Who is the listed applicant for Difiney Advanced Anti Snoring Device 4.0?

The FDA 510(k) record lists Fissiontech, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fissiontech, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250482Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 BlueK233850Difiney Anti Snoring Device

Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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