510(k) K941603

AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE by Allergan Medical Optics — Product Code KYB

K941603 is an FDA 510(k) premarket notification submitted by Allergan Medical Optics for the device "AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE". The FDA issued a decision of Substantially Equivalent on July 6, 1994. The device falls under product code KYB (Lens, Guide, Intraocular), a Class I device regulated under 21 CFR 886.4300. Allergan Medical Optics has at least 6 other 510(k) clearances on record.