510(k) K081720

PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS by Prime Herbs Corporation — Product Code ILY

K081720 is an FDA 510(k) premarket notification submitted by Prime Herbs Corporation for the device "PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS". The FDA issued a decision of Substantially Equivalent on June 16, 2009. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Prime Herbs Corporation has at least 1 other 510(k) clearance on record.