510(k) K854225

ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS by Advanced Medical Technology, Inc. — Product Code HQC

K854225 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Advanced Medical Technology, Inc. has at least 7 other 510(k) clearances on record.