One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series

One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series is an FDA 510(k)-cleared medical device (K143434) manufactured by Abbott Medical Optics, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 5, 2015. Regulation: 8.