# K103368: Hairmax Lasercomb

- Pathway: 510(k) (Traditional)
- Applicant: Lexington International, LLC
- Decided: Apr 6, 2011 after 140 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: 2 generations back to K060305 (2007). 2 ancestors in all.
81 later devices descend from it; 6 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060305: Hairmax Lasercomb, Lexington International, LLC (2007) Summary page 1.
- K093499: Hairmax Lasercomb, Lexington International, LLC (2009) Summary page 1.

## Most influential descendants
- K142573: HairMax LaserComb, HairMax LaserComb (2014), 73 descendants of its own
- K160285: Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 (2016), 59 descendants of its own
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352 (2017), 51 descendants of its own
- K162071: IllumiFlow Laser Cap (2017), 35 descendants of its own
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own

## Indications for use
The HairMax LaserComb Advanced 7 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV. The HairMax LaserComb Lux 9 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV. The HairMax LaserComb Professional 12 is indicated to treat androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss and Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K103368
Methodology: https://510kreport.com/methodology