# K180460: Theradome LH40

- Pathway: 510(k) (Traditional)
- Applicant: Theradome, Inc.
- Decided: May 18, 2018 after 87 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: 7 generations back to K001179 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161046: Laser Helmet LH40-EVO, Theradome, Inc. (2016) Summary page 4.
- K171775: Theradome LH80 PRO, Theradome, Inc. (2018) Summary page 4.

## Indications for use
The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2; both with Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K180460
Methodology: https://510kreport.com/methodology