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Erchonia GVL

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref GVLModel EVRL3,HLS2,GVL

by Erchonia Corporation

Identity

Trade Name
Erchonia GVL EUDAMEDFDA UDI
Generic Name
Musculoskeletal/physical therapy laser, professional FDA UDI
Device Name
Erchonia EVRL, Erchonia XLR8, Erchonia GVL EUDAMED
MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treatment of Acne Vulgaris FDA UDI
Model / Reference
EVRL3,HLS2,GVL EUDAMED
GVL EUDAMEDFDA UDI
Description
MEDICAL - Handheld Low Level Laser - 2 diodes 520nm & 405 nm 7.5 mW - includes induction charger - IFU Reduction Pain, and treatment of Acne Vulgaris FDA UDI

Identifiers

Primary DI / UDI-DI
00858985006278 EUDAMEDFDA UDI
Basic UDI-DI
0858985006HandheldP4 EUDAMED
Direct Marketing DI
00858985006278 EUDAMED
510(k) Number
K221987 FDA UDI
FDA Product Code
NHN FDA UDI
EMDN Code
Z120615 THERAPEUTIC LASERS EUDAMED
GMDN Term
Musculoskeletal/physical therapy laser, professional FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Erchonia GVL by Erchonia Corporation — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Erchonia Corporation
EUDAMED SRN
US-MF-000003834
Authorised Representative
Advena Limited MT-AR-000000234

Sources (3)

  • EUDAMED 92f81459-8c98-477c-a3ed-501dc01d4eaa 61 fields · synced Aug 1, 2026
  • FDA UDI 7fe76197-a75f-45e3-b753-7b9089a15509 34 fields · synced May 29, 2026
  • FDA 510(k) K221987 1 fields · synced May 18, 2026