CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) is an FDA 510(k)-cleared medical device (K970312) manufactured by Flexlens, 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 April 1, 1997. Regulation: 8.