510(k) K160947

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System by Usa Laser Biotech, Inc. — Product Code ILY

K160947 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System". The FDA issued a decision of Substantially Equivalent on July 5, 2016. 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.