510(k) K042256

IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE by Usa Laser Biotech, Inc. — Product Code ILY

K042256 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE". The FDA issued a decision of Substantially Equivalent on November 17, 2004. 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.