# K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jan 23, 2026 after 63 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: 12 generations back to K001179 (2000). 31 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242363: HIGHERDOSE Red Light Hat (HG-120K), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 6.
- K213025: Laser hair growth helmet, Kam Yuen Plastic Products, Ltd. (2022) Summary page 7.

## Most influential descendants
- K260899: Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159) (2026), 0 descendants of its own

## Indications for use
The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

Source page: https://510kreport.com/device/K253669
Methodology: https://510kreport.com/methodology