CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS

CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS is an FDA 510(k)-cleared medical device (K992950) manufactured by Prosthetic Soft Lens Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 1999. Regulation: 8.