# K152019: HairMD

- Pathway: 510(k) (Traditional)
- Applicant: Trophy Skin, Inc.
- Decided: Nov 16, 2015 after 118 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 K122248 (2012). 3 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140931: Igrow II Hair Growth System, Apira Science, Inc. (2014) Summary page 4.
- K141567: Igrow - II Hair Growth System, Igrow Hair Growth System, Apira Science, Inc. (2014) Summary page 4.

## Most influential descendants
- K173729: Revian Red (2018), 19 descendants of its own
- K211038: Biophotas Celluma RESTORE (2021), 9 descendants of its own
- K193008: Tricoglam Home Use (2020), 6 descendants of its own
- K213025: Laser hair growth helmet (2022), 5 descendants of its own
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), 4 descendants of its own

## Indications for use
The HairMD 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 Ila-V and for both, Fitzpatrick Classification of Skin Phototypes of l-IV.

Source page: https://510kreport.com/device/K152019
Methodology: https://510kreport.com/methodology