# K242382: décoLITE LED Device

- Pathway: 510(k) (Traditional)
- Applicant: iSMART Developments, Ltd.
- Decided: Nov 8, 2024 after 88 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: 15 generations back to K943450 (1995). 96 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 103 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191629: faceLITE, Ismart Marketing Svcs, Ltd. (2019) Summary page 5.

## Most influential descendants
- K253073: LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) (2025), 1 descendant of its own
- K261052: LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (2026), 0 descendants of its own
- K254025: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (2026), 0 descendants of its own
- K253279: Feather/numiere 05 06 07 (05) (2025), 0 descendants of its own
- K252272: ORA Method LED Gua Sha (GS-04) (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K242382
Methodology: https://510kreport.com/methodology