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Max Engineering , Ltd.
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SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM is an FDA 510(k)-cleared medical device (K032735) manufactured by Max Engineering , Ltd.. 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 December 2, 2003. Regulation: 8.