510(k) K112016

L-SER KO LAMP by Ya-Man, Ltd. — Product Code ILY

K112016 is an FDA 510(k) premarket notification submitted by Ya-Man, Ltd. for the device "L-SER KO LAMP". The FDA issued a decision of Substantially Equivalent on Feb 10, 2012. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Ya-Man, Ltd. has at least 5 other 510(k) clearances on record.