XOMED THERMAL MYRINGOTOMY SYSTEM

XOMED THERMAL MYRINGOTOMY SYSTEM is an FDA 510(k)-cleared medical device (K820157) manufactured by Xomed, 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 1, 1982. Regulation: 8.