# K192544: Erchonia Emerald

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Jan 13, 2020 after 119 days
- Product code: OLI (Fat Reducing Low Level Laser)
- 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: 1 generation back to K123237 (2013). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142042: Erchonia SHL, Erchonia Corporation (2014) Summary page 4.
- K123237: Zerona 2.0 Laser, Erchonia Corporation (2013) Summary page 4.

## Most influential descendants
- K243811: Erchonia Zerona® VZ8 (2025), 1 descendant of its own
- K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (2026), 0 descendants of its own
- K252574: Erchonia CLX (Model # CFL) (2025), 0 descendants of its own

## Indications for use
Erchonia® Emerald (Model # SHL) Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m².

Source page: https://510kreport.com/device/K192544
Methodology: https://510kreport.com/methodology