# K190685: Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
- Decided: Jul 26, 2019 after 130 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). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162994: Capillus302, Capillus312, Capillus352, Capillus, LLC (2016) Summary page 5.
- K132646: Sunetics Clinical Bio-Stimulation Laser, Sunetics International Marketing Group, LLC (2013) Summary page 5.

## Indications for use
The Hair Growth System (Model: KN-8000A) is a prescription use device intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I- II, and in males with androgenic alopecia who have Norwood Hamilton Classifications IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.

Source page: https://510kreport.com/device/K190685
Methodology: https://510kreport.com/methodology