510(k) K143434

One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series by Abbott Medical Optics, Inc. — Product Code MSS

K143434 is an FDA 510(k) premarket notification submitted by Abbott Medical Optics, Inc. for the device "One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series". The FDA issued a decision of Substantially Equivalent on May 6, 2015. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Abbott Medical Optics, Inc. has at least 10 other 510(k) clearances on record.