# K162106: Micro-current Wrinkle Reduction Facial service, model EP-400

- Pathway: 510(k) (Traditional)
- Applicant: Li-Tek Electronic Technology Corporation
- Decided: Feb 3, 2017 after 189 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011935 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130065: Beautiful Image Facial Sculpting Device, Biosonic Technologies, LLC (2014). Our reading of the summary gave K130045, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Beautiful Image Model 900 Facial Toning Device”.
- K142794: Everyway Facial MENS, Everyway Medical Instruments Co.,Ltd (2015) Summary page 5.
- K103472: Nuface Plus, Carol Cole Company (2011) Summary page 5.
- K141308: Nutra Light Red, Nutra Luxe MD, LLC (2014) Summary page 5.

## Indications for use
The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.

Source page: https://510kreport.com/device/K162106
Methodology: https://510kreport.com/methodology