# K191754: Hair Growth System

- Pathway: 510(k) (Traditional)
- Applicant: Kunshan Bella Optical Technology Co., Ltd.
- Decided: Nov 22, 2019 after 144 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Hair Growth System, Models: SPARK-3 and SPARK-4 are indicated to promote hair growth in females with androgenetic alopecia who have Ludwing-Savin Classifications of I-Ⅱ, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ⅱa-V and for both, Fitzpatrick Classification of Skin Phototypes I to Ⅳ.

Source page: https://510kreport.com/device/K191754
Methodology: https://510kreport.com/methodology