SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT

SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT is an FDA 510(k)-cleared medical device (K003789) manufactured by Specialty Ultravision, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2001. Regulation: 8.