OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE

OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE is an FDA 510(k)-cleared medical device (K875197) manufactured by Pro-Optics, 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 February 8, 1988. Regulation: 8.