# K232356: Laser Cap, Model: Hat-01

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Yjt Technology Co.,Ltd
- Decided: Oct 24, 2023 after 78 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). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203826: LaserCap Family of Lasers 300, 224, 120 & 80, Transdermal Cap, Inc. (2021) Summary page 5.
- 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.

## Indications for use
Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K232356
Methodology: https://510kreport.com/methodology