# K142573: HairMax LaserComb, HairMax LaserComb

- Pathway: 510(k) (Traditional)
- Applicant: Lexington International, LLC
- Decided: Dec 1, 2014 after 80 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.
73 later devices descend from it; 7 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- 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
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), 20 descendants of its own

## Indications for use
The HairMax LaserComb 41 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV. The HairMax LaserComb 82 is indicated to treat Androgenetic alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic alopecia and, promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K142573
Methodology: https://510kreport.com/methodology