# K242747: FAQ™ (302)

- Pathway: 510(k) (Traditional)
- Applicant: Foreo, Inc.
- Decided: Dec 11, 2024 after 90 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K060305 (2007). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210169: Hair Growth Device, Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd. (2021) Summary page 6.
- K142573: HairMax LaserComb, HairMax LaserComb, Lexington International, LLC (2014) Summary page 6.

## Indications for use
FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K242747
Methodology: https://510kreport.com/methodology