
Stackhouse Assoc.
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MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEM is an FDA 510(k)-cleared medical device (K874512) manufactured by Stackhouse Assoc.. 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 26, 1988. Regulation: 8.