FDA.reportPublic FDA data

FibroLux

Primary DI
00852556007008
Brand
FibroLux
Company
Multi Radiance Medical
Model
FibroLux
Catalog number
600-501
Published
2022-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212189000FibroLuxMulti Radiance Medical2022-09-02NHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852556007008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852556007008008525560070088525560070080852556007008

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal infrared phototherapy unit, non-wearableA mains electricity (AC-powered) device intended to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826320694
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852556007374SportLaserSportLaser800-3022025-01-16
00852556007381PainCurePainCure800-3012025-01-16
00852556007350GameDayGameday LaserU800-2002023-07-25
00852556007367GameDayGameday LaserU600-2202023-07-25
00852556007336PainAwayPainAway600-2002021-09-07
00852556007343PainAwayPainAway Home Care600-2042021-09-07
00852556007305MR5MR5 Activ Pro Laser Shower GU600-500G2020-08-28
00852556007312MR5MR5 Activ Pro GU600-400G2020-08-28
00852556007329MR5MR5 Activ Pro LaserStim GU600-408G2020-08-28
00852556007299PainawayPainAwayU800-1002019-06-03
00852556007015MR4MR4 Laser SystemU6002016-09-23
00852556007022MR4MR4 Super Pulsed Laser Console6002016-09-23
00852556007039MR4MR4 LaserStim Emitter650-1082016-09-23
00852556007046MR4MR4 SE25 Standard Emitter650-1132016-09-23
00852556007053MR4MR4 LaserShower 50 4-D Emitter650-1142016-09-23
00852556007060MR4MR4 LaserShower 50 6-D Emitter650-1162016-09-23
00852556007077MR4MR4 ActivU600-3002016-09-23
00852556007084TerraQuantTQ Solo LaserU800-3002016-09-23
00852556007091PainAwayPainAway PostOp LaserU300-1102016-09-23
00852556007107GameDayGameday LaserU300-2002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898616351141Therapy US (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-12-17
06957510600852LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
16957510600019LASPOTWuhan Guangdun Technology Co.,Ltd.NHN2025-09-23
07898616351127Therapy EC (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
07898616351134Therapy XT (FDA)DMC IMPORTACAO E EXPORTACAO DE EQUIPAMENTOS LTDANHN2025-01-21
00627987397499TheralaseTheralase IncNHN2023-12-14
00627987397475TheralaseTheralase IncNHN2023-10-27
00850056256407Collagentex Series Tanses Technologies IncNHN2023-10-16
00850056256445Collagentex Series Tanses Technologies IncNHN2023-10-16
00858985006278Erchonia GVLERCHONIA CORPORATION, LLCNHN2022-10-31
00858985006193FX405ERCHONIA CORPORATION, LLCNHN2020-08-10
00858985006186FX635ERCHONIA CORPORATION, LLCNHN2020-06-19
00859626006343ML 830®MICROLIGHT CORPORATION OF AMERICANHN2019-04-12
B271LDI200P0LD-I 200+Meditech International IncNHN2018-02-01
00869340000305LaserTouchOneLaser Health Technologies, LLCNHN2017-05-11
00858985006001Base StationERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006025EVLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006032EVRLERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006049FX635ERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006063PL TouchERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006087VLSERCHONIA CORPORATION, LLCNHN2016-09-24
00858985006094XLR8ERCHONIA CORPORATION, LLCNHN2016-09-24
B420LD1000LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100A0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100B0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100C0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000100D0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
B420LEP2000PTS0LEP 2000 Photonic Therapy SystemIMI Healing Technologies IncNHN2016-09-22
00859626006008ML 830®MICROLIGHT CORPORATION OF AMERICANHN2016-08-15
00859626006015ML 830®MICROLIGHT CORPORATION OF AMERICANHN2016-08-15