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Intermedic Arfran, SA
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MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) is an FDA 510(k)-cleared medical device (K091323) manufactured by Intermedic Arfran, SA. 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 June 3, 2009. Regulation: 8.