510(k) K950218

OMS SLIMLINE PHACO HANDPIECE by Optical Micro Systems, Inc. — Product Code HQC

K950218 is an FDA 510(k) premarket notification submitted by Optical Micro Systems, Inc. for the device "OMS SLIMLINE PHACO HANDPIECE". The FDA issued a decision of Substantially Equivalent on July 17, 1995. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Optical Micro Systems, Inc. has at least 10 other 510(k) clearances on record.