K251903 is an FDA 510(k) clearance for the Erchonia DPN Laser (Model# EVRL). Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.
Submitted by Erchonia Corporation (Fountain Inn, US). The FDA issued a Cleared decision on February 19, 2026 after a review of 244 days - an extended review cycle.
This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.
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NCT05291975
Completed
Interventional
Industry-sponsored
Clinical Efficacy and Human Factors Validation Testing of the Erchonia EVRL for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
Clinical Efficacy and Human Factors Validation Testing for Prescription Home Use of the Erchonia Corporation EVRL™ for Providing Temporary Relief of Diabetic Peripheral Neuropathy Foot Pain
| Condition studied |
Neuropathy, Diabetic; Neuropathy;Peripheral; Neuropathy, Painful |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Sponsor |
Erchonia Corporation
(industry)
|
Started 2022-02-17
→
Primary completion 2024-10-16
→
Completed 2024-12-12
Primary outcome
Number of Participants With a 30% or Greater Change in Pain Rating on the Visual Analog Scale (VAS)
Secondary outcome
Satisfaction With Study Outcome
View full study on ClinicalTrials.gov