EYE SPHERE, CONFORMERS

EYE SPHERE, CONFORMERS is an FDA 510(k)-cleared medical device (K972661) manufactured by Gulden Ophthalmics. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 2, 1997. Regulation: 8.