
Biolitec Medical Devices, Inc.
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MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE is an FDA 510(k)-cleared medical device (K113709) manufactured by Biolitec Medical Devices, Inc.. 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 19, 2012. Regulation: 8.