# K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
- Decided: Dec 20, 2024 after 84 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: 19 generations back to K943450 (1995). 169 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 171 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221151: Beauty LED Mask, Model: KFB265, Hunan Guangye Biotechnology Co., Ltd. (2022) Summary page 5.
- K230351: LED Facial Mask, Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. (2023) Summary page 6.

## Most influential descendants
- K252189: LED Light Therapy Mask (2311, 2344, 2457, 2458) (2025), 0 descendants of its own

## Indications for use
LED Light Therapy Mask is an over the counter device that is intended to use LED light for the treatment of wrinkles and mild to moderate acne.

Source page: https://510kreport.com/device/K243040
Methodology: https://510kreport.com/methodology