510(k) K161198

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 by Usa Laser Biotech, Inc. — Product Code ILY

K161198 is an FDA 510(k) premarket notification submitted by Usa Laser Biotech, Inc. for the device "Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3". The FDA issued a decision of Substantially Equivalent on July 26, 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.