510(k) K930320

AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR by Allergan Medical Optics — Product Code KYB

K930320 is an FDA 510(k) premarket notification submitted by Allergan Medical Optics for the device "AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR". The FDA issued a decision of Substantially Equivalent on April 7, 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.