MENTOR TONO-PEN 3

MENTOR TONO-PEN 3 is an FDA 510(k)-cleared medical device (K964312) manufactured by Mentor Ophthalmics, 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 November 25, 1996. Regulation: 8.