SP4044 & SP4055 LUX MODULES

SP4044 & SP4055 LUX MODULES is an FDA 510(k)-cleared medical device (K972026) manufactured by Satelec. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 1997. Regulation: 8.