# K120257: MLS, Zerona-AD

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Medical, Inc.
- Decided: May 14, 2012 after 108 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Erchonia® MILS, Zerona is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.

Source page: https://510kreport.com/device/K120257
Methodology: https://510kreport.com/methodology