FDA.reportPublic FDA data

REMY

Primary DI
06974214160789
Brand
REMY
Company
Wuhan Dimed Laser Technology Co., Ltd.
Model
ZFT-15FJ
Device description
REMY Medical Therapy Laser System with Regulation Number: 21 CFR 878.4810, is intended to use in physical therapy, Podiatry and temporary increase of clear nail in patients with onychomycosis. The 510K number is K190034.
Published
2025-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974214160789PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974214160789069742141607896974214160789

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00minus 20 to 70 degree centigrade, RH 10 to 90 percent

Regulatory Flags#

DUNS number
554165991
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974214160796DIMEDCHERYLAS-15N2025-10-17
06974214160819DIMEDCHERYLAS-20N2025-10-17
06974214160802SIRONASIRONA 1002025-10-16
06974214160000DimedBERYLAS-15FJ2021-03-02
06974214160017DimedBERYLAS-15FI2021-03-02
06974214160024DimedBERYLAS-15F2021-03-02
06974214160031DimedBERYLAS-15J2021-03-02
06974214160048DimedBERYLAS-15I2021-03-02
06974214160055DimedBERYLAS-10FJ2021-03-02
06974214160062DimedBERYLAS-10FI2021-03-02
06974214160079DimedBERYLAS-10F2021-03-02
06974214160086DimedBERYLAS-10J2021-03-02
06974214160093DimedBERYLAS-10I2021-03-02
06974214160109DimedCHERYLAS-30F2021-03-02
06974214160116DimedCHERYLAS-30I2021-03-02
06974214160123DimedCHERYLAS-60I2021-03-02
06974214160130DimedCHERYLAS-70I2021-03-02
06974214160147DimedCHERYLAS-30J2021-03-02
06974214160154DimedCHERYLAS-60J2021-03-02
06974214160161DimedCHERYLAS-70J2021-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976812430271Medical Thulium Fiber Laser SystemsRhein Laser Technologies Co.,Ltd.GEX2026-07-30
08800079000039Laser tip-MGTHULASER, Inc.GEX2026-07-29
08800079000046Laser tip-METHULASER, Inc.GEX2026-07-29
08800079000091K2 mobile coverHULASER, Inc.GEX2026-07-29
00841436126366LED Instrument CoverCIVCO MEDICAL INSTRUMENTS CO., INC.ILY2026-07-27
07290110124175FemiLift Sterile SleeveALMA LASERS LTD.GEX2026-07-26
00810140062833RENPHOJoicom CorporationILY2026-07-24
00810140063113RENPHOJoicom CorporationILY2026-07-24
00810140063120RENPHOJoicom CorporationILY2026-07-24
00850083596002LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
00850083596026LaserWrapSPECTRA THERAPY, LLCILY2026-07-24
EOBN210188S0NAOBERON GmbH Fiber TechnologiesGEX2026-07-22
00850026680218Aura WellnessAura Wellness, LLCILY2026-07-21
08800020109439TRI-BEAM ARMJeisys Medical Inc.GEX2026-07-21
08800020111845P-NAIN SYSTEMJeisys Medical Inc.GEX2026-07-21
08800020111852HILTHERAJeisys Medical Inc.ILY2026-07-21
008164690217041150-50TLASER PERIPHERALS, LLCGEX2026-07-20
00816995027850Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16