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Fisma, Inc.
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VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9 is an FDA 510(k)-cleared medical device (K000158) manufactured by Fisma, 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 August 23, 2000. Regulation: 8.