LUMALITE CURE LIGHT, MODEL 2100

LUMALITE CURE LIGHT, MODEL 2100 is an FDA 510(k)-cleared medical device (K002566) manufactured by Lumalite, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 2000. Regulation: 8.