# K252642: Microcurrent Facial Device (CEC101, EEI101)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Dachi Communication Co., Ltd.
- Decided: Nov 19, 2025 after 90 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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: 20 generations back to K943450 (1995). 180 ancestors in all.
No later device cites it as a predicate yet.
0 of 181 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 5.
- K223919: B.Light Clear Evo and B.Light Restore Evo, Bemer Int AG (2023) Summary page 5.

## Indications for use
EC101: Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for : - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. EEI101: Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use. The light treatment of Microcurrent Facial Device is indicated for: - Red light is intended for the treatment of facial wrinkles. - Blue light is intended for the treatment of mild to moderate inflammatory acne. - Mixed light (Red and Blue) is intended for the treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K252642
Methodology: https://510kreport.com/methodology