POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE)

POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) is an FDA 510(k)-cleared medical device (K980818) manufactured by Stephen A. Dunn, 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 March 29, 1998. Regulation: 8.