# K252325: Hair Growth Laser Cap

- Pathway: 510(k) (Traditional)
- Applicant: Cosmo Far East Technology Limited
- Decided: Oct 22, 2025 after 89 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: 7 generations back to K060305 (2007). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173678: Diode Laser Cap, Cosmo Far East Technology Limited (2018) Summary page 5.

## Indications for use
Hair Growth Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K252325
Methodology: https://510kreport.com/methodology