# K122950: Laser Helmet

- Pathway: 510(k) (Traditional)
- Applicant: Theradome, Inc.
- Decided: Jun 14, 2013 after 262 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: 5 generations back to K001179 (2000). 7 ancestors in all.
46 later devices descend from it; 8 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113097: Laser Helmet, Theradome, Inc. (2012) Summary page 1.
- K091496: Mep-90 Hair Growth Stimulation System, Midwest Rf, LLC (2010) Summary page 1.

## Most influential descendants
- K151516: Capillus82 (2015), 24 descendants of its own
- K161875: LaserCap300, LaserCap224, LaserCap120, LaserCap80 (2016), 20 descendants of its own
- 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

## Indications for use
The Theradome Laser Helmet LH80 PRO is an over the counter (OTC)device indicated to treat androgenic alopecia, to Promote hair growth in females with female pattern hair loss (FPHL) 'on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to 1V.

Source page: https://510kreport.com/device/K122950
Methodology: https://510kreport.com/methodology