510(k) K002986

A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 by A.R.C. Laser AG — Product Code HQC

K002986 is an FDA 510(k) premarket notification submitted by A.R.C. Laser AG for the device "A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5". The FDA issued a decision of Substantially Equivalent on Nov 29, 2000. 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.