# K222012: FAQ 101

- Pathway: 510(k) (Traditional)
- Applicant: Foreo, Inc.
- Decided: Apr 5, 2023 after 271 days
- Product code: PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4420
- 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™ 101 devices are over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.

Source page: https://510kreport.com/device/K222012
Methodology: https://510kreport.com/methodology