510(k) K021929

AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM by Axya Medical, Inc. — Product Code LFL

K021929 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 10, 2002. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.