# K161046: Laser Helmet LH40-EVO

- Pathway: 510(k) (Special)
- Applicant: Theradome, Inc.
- Decided: May 12, 2016 after 29 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: 6 generations back to K001179 (2000). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122950: Laser Helmet, Theradome, Inc. (2013) Summary page 4.
- K140931: Igrow II Hair Growth System, Apira Science, Inc. (2014) Summary page 4.
- K142573: HairMax LaserComb, HairMax LaserComb, Lexington International, LLC (2014) Summary page 4.

## Most influential descendants
- K180460: Theradome LH40 (2018), 0 descendants of its own

## Indications for use
The Theradome Laser Helmet LH40 EVO is an over the counter (OTC) device indicated to treat androgenetic alopecia, to promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-11, Fitzpatrick Skin-Types [ to IV.

Source page: https://510kreport.com/device/K161046
Methodology: https://510kreport.com/methodology