# K213027: Laser Hair Growth Comb

- Pathway: 510(k) (Traditional)
- Applicant: Kam Yuen Plastic Products, Ltd.
- Decided: May 26, 2022 after 247 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
The Laser Hair Growth Comb (Model: A-803) is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ha-V or females with androgenic alopecia who have Ludwig-Savin Classifications of 1-4, II-1, 11-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.

Source page: https://510kreport.com/device/K213027
Methodology: https://510kreport.com/methodology