# K172968: Hair Up

- Pathway: 510(k) (Traditional)
- Applicant: Y & J Bio Co., Ltd.
- Decided: Jan 5, 2018 after 101 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: 1 generation back to K141567 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141567: Igrow - II Hair Growth System, Igrow Hair Growth System, Apira Science, Inc. (2014) Summary page 4.

## Indications for use
Promotion of hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Classification Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K172968
Methodology: https://510kreport.com/methodology