510(k) K091726

NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 by Usa Laser Biotech, Inc. — Product Code ILY

K091726 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980". The FDA issued a decision of Substantially Equivalent on October 28, 2009. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Usa Laser Biotech, Inc. has at least 5 other 510(k) clearances on record.