# K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)

- Pathway: 510(k) (Traditional)
- Applicant: Zdeer Technology (Henan) Co., Ltd.
- Decided: Jun 16, 2026 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: 13 generations back to K001179 (2000). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 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 6.
- K213447: LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210., Shenzhen Cosbeauty Technology Co., Ltd. (2022) Summary page 6.
- K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2026) Summary page 6.

## Indications for use
The device is indicated to treat androgenetic alopecia for men and women. It is designed to promote 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-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K260899
Methodology: https://510kreport.com/methodology