# K162578: Zerona Z6 OTC

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Dec 16, 2016 after 92 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K231474: Erchonia Violet ZERONA® Z6 OTC (2023), 2 descendants of its own
- K243811: Erchonia Zerona® VZ8 (2025), 1 descendant of its own
- K252574: Erchonia CLX (Model # CFL) (2025), 0 descendants of its own
- K220519: Erchonia Zerona Z-Bed (2022), 0 descendants of its own

## Indications for use
The ZERONA Z6 OTC Laser is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference.

Source page: https://510kreport.com/device/K162578
Methodology: https://510kreport.com/methodology