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.

Clearance details

Applicant: Erchonia Corporation
Product code: 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 ↗

Recent devices under product code NHN

view all

K254024 — MR5 Activ Pro2026-05-19
K252273 — Therapy US2025-12-12
K241057 — Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)2025-01-24
K232813 — Therapy EC, Therapy XT2024-12-19
K231409 — Erchonia FX-4052023-08-11

More clearances from Erchonia Corporation

view all

K252574 — Erchonia CLX (Model # CFL)2025-12-15
K251843 — Erchonia EVRL2025-09-12
K243811 — Erchonia Zerona® VZ82025-01-10
K231474 — Erchonia Violet ZERONA® Z6 OTC2023-07-21
K221987 — Erchonia GVL2022-09-01

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