510(k) K984143

FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM by Fibra Sonics, Inc. — Product Code HQC

K984143 is an FDA 510(k) premarket notification submitted by Fibra Sonics, Inc. for the device "FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 16, 1999. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Fibra Sonics, Inc. has at least 9 other 510(k) clearances on record.