Erchonia XLR8
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Erchonia XLR8 EUDAMED
- Device Name
- Erchonia EVRL, Erchonia XLR8, Erchonia GVL EUDAMED
- Model / Reference
- EVRL3,HLS2,GVL EUDAMEDHLS2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858985006216 EUDAMED
- Basic UDI-DI
- 0858985006HandheldP4 EUDAMED
- Direct Marketing DI
- 00858985006216 EUDAMED
- 510(k) Number
- K211186 FDA 510(k)
- FDA Product Code
- NHN FDA 510(k)
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5500 FDA 510(k)
- Regulation Number
- 890.5500 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Erchonia XLR8 is a powered light-based laser device designed for non-thermal adjunctive use in pain therapy. Classified as a Class II medical device, it employs non-heating laser technology to target chronic pain conditions. Its primary function aligns with FDA-recognized indications for physical medicine applications, including chronic neck and shoulder pain relief. The device operates without thermal effects, distinguishing it from traditional thermal therapies.
The XLR8 is supplied as a handheld, cord-free instrument with a graphical user interface for user interaction. It is intended for single-use or reusable applications in clinical settings, though sterility requirements are not specified in regulatory data. The device is authorized under FDA 510(k) clearance (K211186) and EU MDR compliance, with multiple registration numbers (e.g., 3011258423) listed under regulation 890.5500. No MRI safety information is provided, and storage conditions are not detailed in the available specifications.
Frequently asked questions
What types of chronic pain conditions is the Erchonia XLR8 specifically designed to address in clinical settings?
The Erchonia XLR8 is FDA-cleared and EU MDR-compliant for non-thermal adjunctive use in pain therapy, with a primary focus on chronic neck and shoulder pain relief. Its classification as a Class II device under the FDA’s Physical Medicine advisory committee aligns it with applications in physical medicine, though it is not limited to these conditions. The device employs non-heating laser technology, distinguishing it from thermal therapies.
How is the Erchonia XLR8 supplied, and can it be reused in clinical environments?
The Erchonia XLR8 is supplied as a handheld, cord-free device with a graphical user interface. While the device is labeled for *single-use or reusable* applications, regulatory data does not specify sterility requirements or reprocessing guidelines. Clinicians should follow facility-specific protocols for reuse to ensure safety and compliance.
What regulatory pathways does the Erchonia XLR8 follow, and how does this affect its availability in different markets?
The Erchonia XLR8 is cleared under the FDA’s 510(k) pathway (K211186) with a decision of *Substantially Equivalent* to a predicate device, categorized under Physical Medicine (product code NHN). It also complies with EU MDR (Medical Device Regulation) and holds multiple registration numbers (e.g., 3011258423) under regulation 890.5500. This dual clearance supports its availability in both U.S. and EU markets, though local compliance requirements may still apply.
Are there any specific storage conditions or MRI safety considerations mentioned for the Erchonia XLR8?
The available specifications for the Erchonia XLR8 do not provide explicit details on storage conditions or MRI safety. Clinicians should refer to manufacturer guidelines or facility protocols for proper handling and storage. Additionally, since no MRI safety information is included, the device should not be used in MRI environments unless confirmed safe by the manufacturer.
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. Sources consulted: XLR8 Handheld Cold Laser Device, Therapy for Pain - Erchonia, Home | Erchonia, XLR8 by Erchonia - The World's Most Advanced Laser, Erchonia XLR8 Cold Laser Therapy - HOME MEDICAL LASER
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 | K211186 | Class II | Active |
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Manufacturer
- Manufacturer
- Erchonia Corporation
Sources (2)
- FDA 510(k) K211186 24 fields · synced Sep 20, 2026
- EUDAMED e8a11929-5359-4ed6-86fa-1a53c398dc54 61 fields · synced Jul 31, 2026