# K251843: Erchonia EVRL

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Sep 12, 2025 after 88 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K943450 (1995). 106 ancestors in all.
No later device cites it as a predicate yet.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220729: The Luminance RED Acne Device, Luminance Medical Ventures, Inc. (2022) Summary page 5.
- K160691: Acne Light Therapy Wand, Zuko, Inc. (2016) Summary page 5.

## Indications for use
The Erchonia EVRL is intended to emit energy in the red and blue region of the spectrum, and is specifically indicated to treat mild to moderate acne.

Source page: https://510kreport.com/device/K251843
Methodology: https://510kreport.com/methodology