# K252414: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Oct 30, 2025 after 90 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: 6 generations back to K122248 (2012). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222081: ID-510 iRestore Elite, Freedom Laser Therapy, Inc. (2022) Summary page 5.

## Indications for use
The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-ll, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K252414
Methodology: https://510kreport.com/methodology