SPECTACLE SUNGLASSES (NON-PERSCRIPTION)

SPECTACLE SUNGLASSES (NON-PERSCRIPTION) is an FDA 510(k)-cleared medical device (K934034) manufactured by H.M.O. Optical, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 17, 1993. Regulation: 8.