# K192627: Laser Hair Growth Cap

- Pathway: 510(k) (Traditional)
- Applicant: Shang FA Biotechnology Co.
- Decided: Dec 13, 2019 after 81 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: 8 generations back to K001179 (2000). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173678: Diode Laser Cap, Cosmo Far East Technology Limited (2018) Summary page 4.
- K171835: Irradiation Aesthetic Device, Chongqing Peninsula Medical Technology Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- 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) (2026), 0 descendants of its own

## Indications for use
Laser Hair Growth 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 Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K192627
Methodology: https://510kreport.com/methodology