# K162652: Smart Photon Micro-current Device, Model: EP-300

- Pathway: 510(k) (Traditional)
- Applicant: Li-Tek Electronic Technology Corporation
- Decided: Oct 25, 2017 after 397 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: 11 generations back to K943450 (1995). 105 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 116 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) Summary page 5.
- K142794: Everyway Facial MENS, Everyway Medical Instruments Co.,Ltd (2015) Summary page 5.
- K121435: Silkn Blue, Home Skinovations, Ltd. (2013) Summary page 5.
- K141308: Nutra Light Red, Nutra Luxe MD, LLC (2014) Summary page 5.

## Most influential descendants
- K241102: Luna 4 plus (2024), 5 descendants of its own
- K213039: Micro-current facial cold and hot service (model: TPML-100) (2022), 4 descendants of its own
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (2025), 3 descendants of its own
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own
- K253712: LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) (2026), 1 descendant of its own

## Indications for use
For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use. For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles, For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.

Source page: https://510kreport.com/device/K162652
Methodology: https://510kreport.com/methodology