# K231146: AliTight

- Pathway: 510(k) (Traditional)
- Applicant: Alic Iotech, LLC
- Decided: Sep 8, 2023 after 140 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140255: Stop U (Packed Black Usa); Stop U (Packed White Usa), Pollogen, Ltd. (2014) Summary page 4.

## Indications for use
The AliTight device is intended for use in the non-invasive heating of facial skin.

Source page: https://510kreport.com/device/K231146
Methodology: https://510kreport.com/methodology