510(k) K051681

DERMILLUME RED, MODEL HR1000 by Care Electronics, Inc. — Product Code ILY

K051681 is an FDA 510(k) premarket notification submitted by Care Electronics, Inc. for the device "DERMILLUME RED, MODEL HR1000". The FDA issued a decision of Substantially Equivalent on July 27, 2005. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500. Care Electronics, Inc. has at least 2 other 510(k) clearances on record.