# K213039: Micro-current facial cold and hot service (model: TPML-100)

- Pathway: 510(k) (Traditional)
- Applicant: Li-Tek Electronics Technology C0., Ltd.
- Decided: May 25, 2022 after 245 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K943450 (1995). 112 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180900: LED Light Therapy Device, Uvbiotek, LLC (2018) Summary page 5.
- K201906: Trinity ELE Plus and Trinity ELE Plus Pro, Carol Cole Company Dba Nuface (2021) Summary page 5.
- K162652: Smart Photon Micro-current Device, Model: EP-300, Li-Tek Electronic Technology Corporation (2017) Summary page 6.

## Most influential descendants
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (2025), 1 descendant of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own
- K260767: Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) (2026), 0 descendants of its own

## Indications for use
Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for over the counter aesthetic use.

Source page: https://510kreport.com/device/K213039
Methodology: https://510kreport.com/methodology