# K252096: Light Therapy Decollete Mask (1019135)

- Pathway: 510(k) (Traditional)
- Applicant: Merchsource, LLC
- Decided: Oct 1, 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: 16 generations back to K943450 (1995). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242382: décoLITE LED Device, iSMART Developments, Ltd. (2024) Summary page 5.

## Indications for use
It is an over-the-counter device that is intended for use in the treatment of wrinkles in the decolletage area.

Source page: https://510kreport.com/device/K252096
Methodology: https://510kreport.com/methodology