FDA applicant

Erchonia Medical, Inc.

Littleton, CO11 decisions2004–20160 recalls

FDA records 11 decisions for Erchonia Medical, Inc. (Littleton, CO) from 2004 to 2016: 10 510(k) clearances and 1 De Novo grant. Most are in product codes NHN (Powered Light Based Laser Non-Thermal…) and OLI (Fat Reducing Low Level Laser). No recall is linked to its devices.

FDA’s records also spell it “Erchonia Medical”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Erchonia Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007high 3 (2013) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Erchonia Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Erchonia Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Erchonia”

FDA records each applicant name separately; these may or may not be the same firm.

Erchonia Corporation 26

Erchonia Medical, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Erchonia”