# K260598: 5 Wavelength LED Facemask (TN2508)

- Pathway: 510(k) (Traditional)
- Applicant: iSMART Developments, Ltd.
- Decided: Jul 24, 2026 after 150 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: 2 generations back to K101190 (2010). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112362: C100 Wrinkle Reduction Device, Silver Bay, LLC (2012) Summary page 5.

## Indications for use
The 5 wavelength LED facemask emits light in the red and near infrared (NIR) region of the light spectrum and is indicated for the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K260598
Methodology: https://510kreport.com/methodology