(MICRO-KERATRON, MICRO DUCT TREPHINE)

(MICRO-KERATRON, MICRO DUCT TREPHINE) is an FDA 510(k)-cleared medical device (K791763) manufactured by Intl. Ophthalmic Industries Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 4, 1979. Regulation: 8.