510(k) K080465

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES by Ws Far IR Medical Technology Co., Ltd. — Product Code ILY

K080465 is an FDA 510(k) premarket notification submitted by Ws Far IR Medical Technology Co., Ltd. for the device "WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES". The FDA issued a decision of Substantially Equivalent on July 18, 2008. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Ws Far IR Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.