NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT) is an FDA 510(k)-cleared medical device (K040913) manufactured by Bausch & Lomb. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 22, 2004. Regulation: 8.