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Usa Laser Biotech, Inc.
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NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 is an FDA 510(k)-cleared medical device (K091726) manufactured by Usa Laser Biotech, Inc.. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2009. Regulation: 8.