510(k) K993046

FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 by Fibra Sonics, Inc. — Product Code FEO

K993046 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000". The FDA issued a decision of Substantially Equivalent on November 22, 1999. The device falls under product code FEO (Lithotriptor, Ultrasonic), a Class II device regulated under 21 CFR 876.4480. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.