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Lutronic Corporation
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SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES is an FDA 510(k)-cleared medical device (K080248) 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 April 22, 2008. Regulation: 8.