# K260202: LED Light Therapy Masks (LumiLips FAC07NA)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Newdermo Biotech Co., Ltd.
- Decided: Mar 23, 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
Longest line of descent: 7 generations back to K101190 (2010). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172662: reVive Perioral, Led Technologies, Inc. (2018) Summary page 5.
- K213024: Oren LED Perioral Light Therapy System, Shenzhen Kaiyan Medical CO, Ltd. (2021) Summary page 6.

## Indications for use
The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

Source page: https://510kreport.com/device/K260202
Methodology: https://510kreport.com/methodology