# K230134: Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002

- Pathway: 510(k) (Traditional)
- Applicant: Hubei Yjt Technology Co.,Ltd
- Decided: May 23, 2023 after 126 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: 3 generations back to K060305 (2007). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103368: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 5.
- K112524: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 6.
- K110233: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 6.

## Most influential descendants
- K251684: Alma TED+ System (2026), 0 descendants of its own
- K242620: Breo Laser Hair Growth Comb (Scalp 3L) (2024), 0 descendants of its own

## Indications for use
Laser Therapy Hair Growth Comb is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K230134
Methodology: https://510kreport.com/methodology