510(k) K162652

Smart Photon Micro-current Device, Model: EP-300 by Li-Tek Electronic Technology Corporation — Product Code NFO

K162652 is an FDA 510(k) premarket notification submitted by Li-Tek Electronic Technology Corporation for the device "Smart Photon Micro-current Device, Model: EP-300". The FDA issued a decision of Substantially Equivalent on Oct 25, 2017. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Li-Tek Electronic Technology Corporation has 2 other 510(k) clearances on record.