510(k) K061080

IR PRO 250 by Lhasa Oms, Inc. — Product Code ILY

K061080 is an FDA 510(k) premarket notification submitted by Lhasa Oms, Inc. for the device "IR PRO 250". The FDA issued a decision of Substantially Equivalent on June 14, 2006. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Lhasa Oms, Inc. has at least 7 other 510(k) clearances on record.