# K163401: Nix Ultra Lice Treatment Kit

- Pathway: 510(k) (Traditional)
- Applicant: Medtech Products, Inc.
- Decided: Mar 21, 2017 after 106 days
- Product code: LJL (Detectors And Removers, Lice, (Including Combs))
- Device class: 1
- Regulation: 21 CFR 880.5960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K822421 (1982). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981147: Clear (TM) Lice Egg Remover System, Care Technologies, Inc. (1998) Summary page 5.

## Indications for use
Nix® Ultra Lice Treatment Kit is intended to kill and remove head lice and their eggs from adults and children two years of age or older.

Source page: https://510kreport.com/device/K163401
Methodology: https://510kreport.com/methodology