# K262254: Hair Growth Comb (X-GC01)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Ashmore Health Technology Co., Ltd.
- Decided: Sep 23, 2026 after 83 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
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
Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, 1I-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of lla to V and who both have Fitzpatrick Skin Types | to IV.

Source page: https://510kreport.com/device/K262254
Methodology: https://510kreport.com/methodology