FDA.reportPublic FDA data

SIRONA

Primary DI
06974214160802
Brand
SIRONA
Company
Wuhan Dimed Laser Technology Co., Ltd.
Model
SIRONA 100
Device description
The SIRONA 100 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the Handpiece. The device is activated by means of a footswitch or a finger switch on the handpiece.
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
06974214160802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974214160802069742141608026974214160802

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

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
06974214160789REMYZFT-15FJ2025-10-14
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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