# K191629: faceLITE

- Pathway: 510(k) (Traditional)
- Applicant: Ismart Marketing Svcs, Ltd.
- Decided: Sep 12, 2019 after 85 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: 14 generations back to K943450 (1995). 95 ancestors in all.
71 later devices descend from it; 7 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170984: LG Beauty Led Mask, Lg Electronics (2017) Summary page 6.

## Most influential descendants
- K202390: Aduro Light Beauty Mask (2021), 39 descendants of its own
- K213184: MZ Skin LightMAX Supercharged LED Mask 2.0 (2021), 35 descendants of its own
- K220168: Skin Care Beauty Mask (Model: MJ-06) (2022), 34 descendants of its own
- K230351: LED Facial Mask (2023), 33 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own

## Indications for use
The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K191629
Methodology: https://510kreport.com/methodology