# K261253: Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)

- Pathway: 510(k) (Traditional)
- Applicant: Ziree Co., Ltd.
- Decided: Jun 26, 2026 after 71 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: 9 generations back to K001179 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192627: Laser Hair Growth Cap, Shang FA Biotechnology Co. (2019) Summary page 5.

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

Source page: https://510kreport.com/device/K261253
Methodology: https://510kreport.com/methodology