FDA.reportPublic FDA data

EVRL

Primary DI
00858985006032
Brand
EVRL
Company
ERCHONIA CORPORATION, LLC
Model
EVRL
Catalog number
EVRL
Device description
MEDICAL - Handheld Low Level Laser - 2 diodes 640nm & 405 nm 7.5 mW - includes induction charger - IFU Neck and Shoulder Pain Reduction, treatment of inflammatory Acne Vulgaris, and Reduction of Diabetic Peripheral Neuropathy Foot Pain
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain TherapyPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858985006032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858985006032008589850060328589850060320858985006032

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

Contacts#

Phone, Email table
PhoneEmail
(888) 242-0571info@erchonia.com

Regulatory Flags#

DUNS number
004053174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858985006391Erchonia CLXCFLCFL2026-07-21
00858985006292Erchonia Zerona VZ8VZ82025-02-25
00858985006261Erchonia Zerona Z-BedJZB2022-10-31
00858985006018EmeraldSHLSHL2016-09-24
00858985006070VerjuCLSCLS2016-09-24
00858985006100Zerona 2.0GLSGLS2016-09-24
00858985006117Zerona ADARCARC2016-09-24
00858985006124Zerona Z6SHRSHR2016-09-24
00858985006360EVRL-OTCEVRL3-OTC2026-02-09
00858985006193FX405MLS-AC2020-08-10
00858985006278Erchonia GVLGVL2022-10-31
00858985006186FX635HPS2HPS22020-06-19
00858985006001Base StationBSTBST2016-09-24
00858985006025EVLEVLEVL2016-09-24
00858985006049FX635HPSHPS2016-09-24
00858985006063PL TouchPLTPLT2016-09-24
00858985006087VLSVLSVLS2016-09-24
00858985006094XLR8HLSHLS2016-09-24
00858985006155AdjustorVA3VA32020-06-19
00858985006162PercussorVP3VP32020-06-19

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