FDA.reportPublic FDA data

Lunula

Primary DI
00858985006056
Brand
Lunula
Company
ERCHONIA CORPORATION, LLC
Model
FFS
Catalog number
FFS
Device description
MEDICAL - Floor Model Low Level Laser - 2 diodes 635nm & 405nm - IFU Reduction Onychomycosis
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858985006056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858985006056008589850060568589850060560858985006056

GMDN Terms#

Term, Definition table
TermDefinition
Nail laser phototherapy unitA portable, mains electricity (AC-powered), laser-emitting device intended to treat nail fungal infection (onychomycosis) using low-level laser treatment (LLLT). It typically consists of an electronic unit with a digital display and a treatment platform where the foot/hand is placed to receive LLLT; it typically includes protective eyewear. It is intended to be used by a healthcare provider in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
004053174
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858985006360EVRL-OTCEVRL3-OTC2026-02-09
00858985006292Erchonia Zerona VZ8VZ82025-02-25
00858985006193FX405MLS-AC2020-08-10
00858985006278Erchonia GVLGVL2022-10-31
00858985006186FX635HPS2HPS22020-06-19
00858985006001Base StationBSTBST2016-09-24
00858985006025EVLEVLEVL2016-09-24
00858985006032EVRLEVRLEVRL2016-09-24
00858985006049FX635HPSHPS2016-09-24
00858985006063PL TouchPLTPLT2016-09-24
00858985006087VLSVLSVLS2016-09-24
00858985006094XLR8HLSHLS2016-09-24
00858985006261Erchonia Zerona Z-BedJZB2022-10-31
00858985006155AdjustorVA3VA32020-06-19
00858985006162PercussorVP3VP32020-06-19
00858985006018EmeraldSHLSHL2016-09-24
00858985006124Zerona Z6SHRSHR2016-09-24
00858985006100Zerona 2.0GLSGLS2016-09-24
00858985006117Zerona ADARCARC2016-09-24
00858985006070VerjuCLSCLS2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898786930030ZYE-ULTRA FDAVYDENCE MEDICALPDZ2026-02-18
07898786930047ONE FDAVYDENCE MEDICALPDZ2026-02-18
06974214160802SIRONAWuhan Dimed Laser Technology Co., Ltd.PDZ2025-10-16
06974214160789REMYWuhan Dimed Laser Technology Co., Ltd.PDZ2025-10-14
16977331780035GIGAAGigaalaser Company Ltd.PDZ2025-08-13
00086001245602TFX-LT2000 Therapy LightToeFX IncPDZ2024-11-15
00817495024653GMAX Pro Laser SystemCandela CorporationPDZ2024-09-24
07898961835013ETHEREA-MXVYDENCE MEDICALPDZ2024-05-27
07898961835037LongPulseVYDENCE MEDICALPDZ2024-05-27
07898961835204ZYE YAGVYDENCE MEDICALPDZ2024-05-27
07898961835211ZYE ALXVYDENCE MEDICALPDZ2024-05-27
078989618352425-15/ltVYDENCE MEDICALPDZ2024-05-27
00817495023564GMAX Pro Laser SystemCandela CorporationPDZ2022-12-16
00854103007059LightForce EXPiLITECURE LLCPDZ2017-07-24
00854103007035LightForce EXPLITECURE LLCPDZ2017-02-07
00816722021205Genesis PlusCUTERA, INC.PDZ2016-09-23
00816722023209Genesis Plus 1 mm Spot Size AdapterCUTERA, INC.PDZ2016-09-23
03830054230170Fotona XP FocusFOTONA d.o.o.PDZ2016-09-19
03830054230224Fotona XP FocusFOTONA d.o.o.PDZ2016-09-19
03830054230231Fotona XP-2 FocusFOTONA d.o.o.PDZ2016-09-19
03830054230095Lightwalker DTFOTONA d.o.o.PDZ2016-09-19
03830054230194Lightwalker ATFOTONA d.o.o.PDZ2016-09-19
03830054230293Lightwalker ST-EFOTONA d.o.o.PDZ2016-09-19
03830054230491Lightwalker DT STANDFOTONA d.o.o.PDZ2016-09-19
03830054230590Lightwalker ST-E STANDFOTONA d.o.o.PDZ2016-09-19
03830054230798Lightwalker DT ADVANCEDFOTONA d.o.o.PDZ2016-09-19
03830054230897Lightwalker ST-E ADVANCEDFOTONA d.o.o.PDZ2016-09-19
08033945934347Hyperblue plusQUANTA SYSTEM SPAPDZ2016-08-18