510(k) K091497

K-LASER K-1200, MODEL 12 W by Eltech S.R.L — Product Code ILY

K091497 is an FDA 510(k) premarket notification submitted by Eltech S.R.L for the device "K-LASER K-1200, MODEL 12 W". The FDA issued a decision of Substantially Equivalent on Aug 19, 2009. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Eltech S.R.L has 2 other 510(k) clearances on record.