# K261496: LED Light Therapy Masks (PE748, PE749, PE756)

- Pathway: 510(k) (Traditional)
- Applicant: Duplex International Trading Limited
- Decided: Aug 4, 2026 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: 19 generations back to K943450 (1995). 125 ancestors in all.
No later device cites it as a predicate yet.
0 of 126 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023), Light Tree Ventures Europe B.V. (2023) Summary page 5.

## Indications for use
The LED Light Therapy Mask (Model: PE748) is an Over-the-Counter (OTC) device, the Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The Purple Light (Red + Blue light) mode intended for mild to moderate inflammatory acne. The LED Light Therapy Mask (Model: PE749) is an Over-the-Counter (OTC) device, For the face mask: The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The Purple Light (Red + Blue light) mode intended for mild to moderate inflammatory acne. For the neck mask: The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles; The LED Light Therapy Mask (Model: PE756) is an Over-the-Counter (OTC) device, The Red light mode (Red + Near-Infrared light) intended for treatment of wrinkles.

Source page: https://510kreport.com/device/K261496
Methodology: https://510kreport.com/methodology