
Biolitec Sia
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ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER is an FDA 510(k)-cleared medical device (K130681) manufactured by Biolitec Sia. 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 January 7, 2014. Regulation: 8.