SPECTRA SP II, SPECTRA DENTA II

SPECTRA SP II, SPECTRA DENTA II is an FDA 510(k)-cleared medical device (K091320) manufactured by Lutronic Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 18, 2009. Regulation: 8.