# K252142: Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
- Decided: Dec 5, 2025 after 150 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). 173 ancestors in all.
No later device cites it as a predicate yet.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190443: MMSphere, Galactic Beauty, LLC (2019) Summary page 5.
- K241718: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), Shenzhen Aozemei Technology Co., Ltd. (2024) Summary page 5.

## Indications for use
Multi-functional Facial Beauty Device (model: SKB-1909): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. - Red light is intended for the treatment of facial wrinkles. Multi-functional Facial Beauty Device (model: SKB-1703): - Blue light is intended for the treatment of facial mild to moderate inflammatory acne. Multi-functional Facial Beauty Device (models SKB-1803, SKB-1809, SBK-2109, SKB-2129, SKB-2208PRO and SKB-2209): - Red light is intended for the treatment of facial wrinkles.

Source page: https://510kreport.com/device/K252142
Methodology: https://510kreport.com/methodology