# K142824: LX-100 Hair Growth Stimulation System

- Pathway: 510(k) (Traditional)
- Applicant: Hairlabs International, Inc.
- Decided: Apr 14, 2015 after 196 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.
No later device cites it as a predicate yet.
0 of 9 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 5.
- K122950: Laser Helmet, Theradome, Inc. (2013) Summary page 5.

## Indications for use
The LX-100 is a non-heating lamp as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use for the treatment of androgenic alopecia in females; the LX-100 is indicated to promote hair growth of females with androgenetic alopecia who have Ludwig and Savin Hair Loss Scale classifications of I to II and who have been determined to have a Fitzpatrick Skin Typing of I to IV.

Source page: https://510kreport.com/device/K142824
Methodology: https://510kreport.com/methodology