# K200929: Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
- Decided: Jun 3, 2020 after 57 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). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173846: DermaScalp Laser Cap, Dermascalp, LLC (2018) Summary page 5.
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 5.
- K151662: iRestore, Freedom Laser Therapy, Inc. (2016) Summary page 5.
- K183417: iRestore Professional 282, Freedom Laser Therapy, Inc. (2019) Summary page 5.

## Indications for use
The Hair Growth System (Model: KN-8000B/KN-8000C/KN-8000D/KN-8000E) is intended for the promotion of hair growth in females with androgenic alopecia who have Ludwig-Savin Classifications I-II, and in males with androgenetic alopecia who have Norwood Hamilton Classifications Ila-V; and both genders having Fitzpatrick Classification of Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K200929
Methodology: https://510kreport.com/methodology