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Erchonia EVRL

by Erchonia Corporation

Ref EVRL3Model EVRL3,HLS2,GVL

Erchonia EVRL (EVRL3) is a Class IIa device made by Erchonia Corporation, registered in EUDAMED on 22 Apr 2026 (Basic UDI-DI 0858985006HandheldP4) and cleared under FDA 510(k) K251843 on 12 Sep 2025 (2 earlier submissions), active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K251843↗

+2 more

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0858985006HandheldP4 Basic UDI-DI 00858985006223UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK251843 Date12 Sep 2025IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0858985006HandheldP4 registered 22 Apr 2026 Active
  • FDA 510(k) K251843 decided 12 Sep 2025 Active· +2 more in the status table

Timeline

4 dated events

  1. Cleared FDA 510(k) K152196
  2. Cleared FDA 510(k) K191257
  3. Cleared FDA 510(k) K251843
  4. Registered EUDAMED 0858985006HandheldP4

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Device name
Erchonia EVRL, Erchonia XLR8, Erchonia GVL
Model / reference
EVRL3, HLS2, GVL
Primary DI / UDI-DI
00858985006223
Basic UDI-DI
0858985006HandheldP4
Direct marketing DI
00858985006223
EMDN code
Z120615 Therapeutic lasers
Device class
Class IIa
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000003834
Authorised representative
Advena Limited MT-AR-000000234

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Properties

Other properties (14, all answered No)