510(k) K072260

NUFACE, MODEL NU-4003 by Carol Cole Company — Product Code NFO

K072260 is an FDA 510(k) premarket notification submitted by Carol Cole Company for the device "NUFACE, MODEL NU-4003". The FDA issued a decision of Substantially Equivalent on November 27, 2007. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Carol Cole Company has at least 5 other 510(k) clearances on record.