Erchonia FX-405— 510(k) K231409

Substantially Equivalent

Erchonia Corporation

FDA 510(k) clearance K231409 for Erchonia FX-405, Substantially Equivalent on 2023-08-11. 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: 2023-05-15
Decision date: 2023-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NHN

K254024 — MR5 Activ Pro2026-05-19
K251903 — Erchonia DPN Laser (Model# EVRL)2026-02-19
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

More clearances from Erchonia Corporation

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.