# K214101: Project E Beauty LED Light Therapy Mask (Model: PE730)

- Pathway: 510(k) (Traditional)
- Applicant: Duplex International Trading Limited
- Decided: Mar 23, 2022 after 84 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). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180856: Neutrogena Light Therapy Aging Mask+, Johnson & Johnson Consumer, Inc. (2018) Summary page 5.
- K180847: Neutrogena Light Therapy Acne Mask+, Johnson & Johnson Consumer, Inc. (2018) Summary page 5.

## Indications for use
The Project E Beauty LED Light Therapy Mask is an over the counter device that is indicated for the treatment of full face wrinkles and mild to moderate acne.

Source page: https://510kreport.com/device/K214101
Methodology: https://510kreport.com/methodology