510(k) K261086

Break Wave by Sonomotion, Inc. — Product Code LNS

K261086 is an FDA 510(k) premarket notification submitted by Sonomotion, Inc. for the device "Break Wave". The FDA issued a decision of Substantially Equivalent on April 29, 2026. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Sonomotion, Inc. has at least 2 other 510(k) clearances on record.