PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480

PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 is an FDA 510(k)-cleared medical device (K912112) manufactured by Tomey Corporation USA. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 16, 1991. Regulation: 8.