510(k) K081545

ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 by Advanced Medical Optics, Inc. — Product Code MSS

K081545 is an FDA 510(k) premarket notification submitted by Advanced Medical Optics, Inc. for the device "ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30". The FDA issued a decision of Substantially Equivalent on October 2, 2008. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Advanced Medical Optics, Inc. has at least 7 other 510(k) clearances on record.