
Biolitec Sia (Latvia)
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TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K120437) manufactured by Biolitec Sia (Latvia). 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 25, 2012. Regulation: 8.