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

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Primary DI, Brand, Company table
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06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
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