# K191154: Hair Boom 69

- Pathway: 510(k) (Traditional)
- Applicant: Wontech
- Decided: Jul 29, 2019 after 89 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: 10 generations back to K001179 (2000). 26 ancestors in all.
3 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)
- K182562: Hair Boom 69, Wontech (2018) Summary page 4.

## Most influential descendants
- 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 Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of Ila - V and for both, Fitzpatrick Classifications of Skin Phototypes I - IV.

Source page: https://510kreport.com/device/K191154
Methodology: https://510kreport.com/methodology