510(k) K141861

HILTHERA 4.0 by Jeisys Medical, Inc. — Product Code ILY

K141861 is an FDA 510(k) premarket notification submitted by Jeisys Medical, Inc. for the device "HILTHERA 4.0". The FDA issued a decision of Substantially Equivalent on January 7, 2015. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Jeisys Medical, Inc. has at least 10 other 510(k) clearances on record.