SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)

SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS) is an FDA 510(k)-cleared medical device (K861684) manufactured by Seiko Optical Products of America, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 8, 1986. Regulation: 8.