510(k) K142561

LM-9300 ELMA Lithotripter by Lite-Med, Inc. — Product Code LNS

K142561 is an FDA 510(k) premarket notification submitted by Lite-Med, Inc. for the device "LM-9300 ELMA Lithotripter". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Lite-Med, Inc. has at least 2 other 510(k) clearances on record.