# K180885: HairMax Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lexington International, LLC
- Decided: Jun 20, 2018 after 77 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: 8 generations back to K001179 (2000). 24 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173678: Diode Laser Cap, Cosmo Far East Technology Limited (2018) Summary page 4.
- K163170: Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352, Capillus, LLC (2017) Summary page 4.
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80, Transdermal Cap, Inc. (2016) Summary page 4.

## Most influential descendants
- K182562: Hair Boom 69 (2018), 4 descendants of its own
- K191154: Hair Boom 69 (2019), 3 descendants of its own
- K192425: Hair Boom 69, Hair Boom Air, Ulike Hair UpUp (2019), 2 descendants of its own
- K223862: Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp (2023), 1 descendant of its own
- K240064: Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom (2024), 0 descendants of its own

## Indications for use
The HairMax Laser 272, 202 and 80 are indicated to promote hair growth in males with androgentic alopecia who have Norwood-Hamilton Classifications of IIa - V, or females with androgenetic alopecia who have Ludwig-Savin Classifications I - II or Frontal and for both with Fitzpatrick Skin Phototypes I- IV.

Source page: https://510kreport.com/device/K180885
Methodology: https://510kreport.com/methodology