510(k) K201484

Somnos Anti-Snoring Mouth Guard by Koncept Innovators, LLC — Product Code LRK

K201484 is an FDA 510(k) premarket notification submitted by Koncept Innovators, LLC for the device "Somnos Anti-Snoring Mouth Guard". The FDA issued a decision of Substantially Equivalent on November 23, 2020. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Koncept Innovators, LLC has at least 2 other 510(k) clearances on record.