# K111714: Hairmax Dual 12

- Pathway: 510(k) (Traditional)
- Applicant: Lexington International, LLC
- Decided: Aug 16, 2011 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: 3 generations back to K060305 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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 1.
- K110233: Hairmax Lasercomb, Lexington International, LLC (2011) Summary page 1.

## Indications for use
The HairMax Dual 12 is indicated to Treat Androgenetic Alopecia and Promote Hair Growth in Females who have Ludwig (Savin) Scale 1-4, H1-, 11-2, or frontal and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K111714
Methodology: https://510kreport.com/methodology