# K171775: Theradome LH80 PRO

- Pathway: 510(k) (Traditional)
- Applicant: Theradome, Inc.
- Decided: Jan 9, 2018 after 209 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 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 5.

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

## Indications for use
The Theradome LH80 PRO 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/K171775
Methodology: https://510kreport.com/methodology