# K250308: Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Boyuan Intelligent Technology Co.,Ltd
- Decided: Apr 29, 2025 after 85 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 K001179 (2000). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162782: iHelmet Hair Growth System, Slinph Technologies Co., Ltd. (2017) Summary page 6.

## Most influential descendants
- K261675: CHZL Red Light Therapy Hair Growth Cap (Model (s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) (2026), 0 descendants of its own

## Indications for use
Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with and rogenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K250308
Methodology: https://510kreport.com/methodology