# K254007: LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

- Pathway: 510(k) (Traditional)
- Applicant: SZ KKS Silicone&Electronic Co., Ltd.
- Decided: Feb 12, 2026 after 59 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
LED Light Therapy Silicone Face 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/K254007
Methodology: https://510kreport.com/methodology