510(k) K101893

NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS by Usa Laser Biotech, Inc. — Product Code ILY

K101893 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS". The FDA issued a decision of Substantially Equivalent on February 17, 2011. 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.