510(k) K151298

Gemini XXP-HP by Dornier Medtech America — Product Code LNS

K151298 is an FDA 510(k) premarket notification submitted by Dornier Medtech America for the device "Gemini XXP-HP". The FDA issued a decision of Substantially Equivalent on July 30, 2015. 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.