LIFESTYLE BREAK THRU (POLYMACON)

LIFESTYLE BREAK THRU (POLYMACON) is an FDA 510(k)-cleared medical device (K965012) manufactured by The Lifestyle Co., 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 March 10, 1997. Regulation: 8.