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Erchonia EVRL
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref EVRL3Model EVRL3,HLS2,GVL
Identity
- Trade Name
- Erchonia EVRL EUDAMED
- Device Name
- Erchonia EVRL, Erchonia XLR8, Erchonia GVL EUDAMED
- Model / Reference
- EVRL3,HLS2,GVL EUDAMEDEVRL3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00858985006223 EUDAMED
- Basic UDI-DI
- 0858985006HandheldP4 EUDAMED
- Direct Marketing DI
- 00858985006223 EUDAMED
- EMDN Code
- Z120615 THERAPEUTIC LASERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Erchonia EVRL by Erchonia Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152196 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K251843 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K191257 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0858985006HandheldP4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Erchonia Corporation
- EUDAMED SRN
- US-MF-000003834
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 7022a4ca-5d4e-4ce2-b3ef-fcab6a5f6141 61 fields · synced Jul 11, 2026
- FDA 510(k) K152196 1 fields · synced May 18, 2026