510(k) K103511

LITECURE THERAPY SYSTEM by Litecure, LLC — Product Code ILY

K103511 is an FDA 510(k) premarket notification submitted by Litecure, LLC for the device "LITECURE THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 2011. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Litecure, LLC has at least 6 other 510(k) clearances on record.