OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT)

OPTICAL FRAME (HELEN,ARNOLD,VANA,BRUCE,MATT) is an FDA 510(k)-cleared medical device (K910134) manufactured by Kentucky Optical Co.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 14, 1991. Regulation: 8.