# K251903: Erchonia DPN Laser (Model# EVRL)

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Feb 19, 2026 after 244 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K152196 (2016). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191257: Erchonia EVRL, Erchonia Corporation (2019) Summary page 5.

## Indications for use
The Erchonia® DPN Laser is indicated while using the red and violet diode simultaneously for prescription home use as an adjunctive treatment in providing temporary relief of diabetic peripheral neuropathy foot pain.

Source page: https://510kreport.com/device/K251903
Methodology: https://510kreport.com/methodology