510(k) K003512

LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II by A.R.C. Laser AG — Product Code HQC

K003512 is an FDA 510(k) premarket notification submitted by A.R.C. Laser AG for the device "LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II". The FDA issued a decision of Substantially Equivalent on Feb 8, 2001. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. A.R.C. Laser AG has at least 3 other 510(k) clearances on record.