510(k) K170122

Delta III Lithotripter by Dornier Medtech America — Product Code LNS

K170122 is an FDA 510(k) premarket notification submitted by Dornier Medtech America for the device "Delta III Lithotripter". The FDA issued a decision of Substantially Equivalent on June 28, 2017. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Dornier Medtech America has at least 10 other 510(k) clearances on record.