# K202983: easy Hairfull

- Pathway: 510(k) (Traditional)
- Applicant: Y & J Bio Co., Ltd.
- Decided: Dec 8, 2020 after 69 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: 3 generations back to K122248 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180617: Hair Up, Y & J Bio Co., Ltd. (2018) Summary page 4.

## Indications for use
The easy Hairfull is intended to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ha to V and Fitzpatrick Classification of Skin Phototypes I to IV, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of 1-Il and Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K202983
Methodology: https://510kreport.com/methodology