510(k) K253355

Difiney Advanced Anti Snoring Device 4.0 by Fissiontech, LLC — Product Code LRK

K253355 is an FDA 510(k) premarket notification submitted by Fissiontech, LLC for the device "Difiney Advanced Anti Snoring Device 4.0". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Fissiontech, LLC has at least 2 other 510(k) clearances on record.