# K211681: EON

- Pathway: 510(k) (Traditional)
- Applicant: Dominion Aesthetic Technologies, Inc.
- Decided: Mar 30, 2022 after 302 days
- Product code: PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 183 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160470: SculpSure, Cynosure, Inc. (2016) Summary page 7.

## Most influential descendants
- K222226: EON (2023), 0 descendants of its own

## Indications for use
The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

Source page: https://510kreport.com/device/K211681
Methodology: https://510kreport.com/methodology