# K152196: Erchonia EVRL

- Pathway: 510(k) (Traditional)
- Applicant: Erchonia Corporation
- Decided: Feb 18, 2016 after 197 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K191257: Erchonia EVRL (2019), 2 descendants of its own
- K251903: Erchonia DPN Laser (Model# EVRL) (2026), 0 descendants of its own
- K221987: Erchonia GVL (2022), 0 descendants of its own

## Indications for use
The Erchonia® EVRL laser is generally indicated: a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

Source page: https://510kreport.com/device/K152196
Methodology: https://510kreport.com/methodology