OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES)

OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) is an FDA 510(k)-cleared medical device (K983278) manufactured by Alden Optical Labs., 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 November 24, 1998. Regulation: 8.