Device Classification Name lenses, soft contact, daily wear 510(k) Number K133176 Device Name AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL Applicant CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY duluth, GA 30097 Applicant Contact martina heim, ph.d., rac Correspondent CIBA VISION CORPORATION 11460 JOHNS CREEK PARKWAY duluth, GA 30097 Correspondent Contact martina heim, ph.d., rac Regulation Number 886.5925 Classification Product Code LPL Date Received 10/17/2013 Decision Date 01/29/2014 Decision substantially equivalent (SESE) Regulation Medical Specialty Ophthalmic 510k Review Panel Ophthalmic summary summary Type Traditional Clinical Trials NCT01338402

NCT01398787

NCT01440322

NCT01614678

NCT01635920

NCT01635933

NCT01782482

Reviewed by Third Party No Combination Product No