# K123237: Zerona 2.0 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Jan 25, 2013 after 101 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K192544: Erchonia Emerald (2020), 3 descendants of its own
- K243811: Erchonia Zerona® VZ8 (2025), 1 descendant of its own
- K192275: invisa-RED ELITE (2020), 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
The Erchonia® ZeronaTM 2.0 Laser is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

Source page: https://510kreport.com/device/K123237
Methodology: https://510kreport.com/methodology