# K113097: Laser Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Theradome, Inc.
- Decided: Mar 2, 2012 after 135 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: 4 generations back to K001179 (2000). 6 ancestors in all.
57 later devices descend from it; 4 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091496: Mep-90 Hair Growth Stimulation System, Midwest Rf, LLC (2010) Summary page 1.

## Most influential descendants
- K150613: LaserCap LC Pro and LC Elite (2015), 46 descendants of its own
- K122950: Laser Helmet (2013), 46 descendants of its own
- K153618: Capillus202 (2016), 44 descendants of its own
- K151516: Capillus82 (2015), 24 descendants of its own
- K162782: iHelmet Hair Growth System (2017), 22 descendants of its own

## Indications for use
The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopecia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.

Source page: https://510kreport.com/device/K113097
Methodology: https://510kreport.com/methodology