# K253683: FAQ™ (LED Panel); FAQ™ (Dual LED Panel)

- Pathway: 510(k) (Traditional)
- Applicant: Foreo, Inc.
- Decided: Feb 20, 2026 after 91 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
FAQ™ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light

Source page: https://510kreport.com/device/K253683
Methodology: https://510kreport.com/methodology
