LEMPERT OPTIC DISC ANALYSIS SYSTEM

LEMPERT OPTIC DISC ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K923708) manufactured by Lempert Ophthalmic Instruments. 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 18, 1993. Regulation: 8.