Erchonia DPN Laser (Model EVRL)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251903 FDA 510(k)
- FDA Product Code
- NHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Erchonia DPN Laser (Model EVRL) is a powered, light-based laser instrument designed for non-thermal adjunctive use in pain therapy. Classified as a Class II device under FDA regulations, it operates without heating effects to support physical medicine applications, as defined by the Physical Medicine advisory committee.
This device is supplied as a reusable medical instrument, intended for use in clinical settings where adjunctive pain management is required. It is not sterile and must be cleaned and maintained according to manufacturer guidelines. The device carries FDA 510(k) clearance and is subject to the Medical Devices Regulation (MDR) in the European Union, with a registration number and product code (NHN) as specified. No MRI safety information is provided in the available data.
Frequently asked questions
What is the primary clinical use of the Erchonia DPN Laser (Model EVRL) in pain management?
The Erchonia DPN Laser (Model EVRL) is designed as a non-thermal, adjunctive tool for pain therapy within physical medicine applications. It is not intended to replace conventional treatments but is meant to be used alongside them to support pain management in clinical settings.
Is the Erchonia DPN Laser (Model EVRL) a single-use or reusable device, and what maintenance is required?
The Erchonia DPN Laser (Model EVRL) is a reusable medical instrument and must be cleaned and maintained according to the manufacturer’s guidelines. Since it is not sterile, proper disinfection protocols are essential before reuse.
What regulatory pathways has the Erchonia DPN Laser (Model EVRL) followed for market authorization?
The device holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II device with a decision code of *SESE* (Substantially Equivalent). It is also subject to the EU Medical Devices Regulation (MDR) with assigned registration numbers and product code *NHN*.
Does the Erchonia DPN Laser (Model EVRL) have any specific safety considerations for use in MRI environments?
The provided data does not include MRI safety information for the Erchonia DPN Laser (Model EVRL). Clinicians should verify compatibility with MRI environments before use, as no explicit clearance or safety assurances are documented.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251903 | Class II | Active |
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Manufacturer
- Manufacturer
- Erchonia Corporation
Sources (2)
- FDA 510(k) K251903 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026