Erchonia DPN Laser (Model# EVRL)— 510(k) K251903

Name: FDA 510(k) clearance K251903
Creator: U.S. Food and Drug Administration
Published: 2026-02-19

Substantially Equivalent

Erchonia Corporation

FDA 510(k) clearance K251903 for Erchonia DPN Laser (Model# EVRL), Substantially Equivalent on 2026-02-19. Applicant: Erchonia Corporation. Device class: 2.

Summary

Erchonia's Erchonia DPN Laser carries Model# EVRL in its name. It's filed under product code NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy), and the record doesn't describe the laser further.

Class II, 21 CFR 890.5500. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).

Erchonia filed from Fountain Inn, South Carolina. Review took 244 calendar days (June 20, 2025 to February 19, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant: Erchonia Corporation
Product code: Product code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2025-06-20
Decision date: 2026-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fountain Inn, SC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.