FDA.reportPublic FDA data

Lightwalker ST-E

Primary DI
03830054230293
Brand
Lightwalker ST-E
Company
FOTONA d.o.o.
Model
M002-6A/2
Device description
The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery.
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating
NVKLaser, Dental, Soft Tissue
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
NVKLaser, Dental, Soft TissueGeneral, Plastic Surgery2
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830054230293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830054230293038300542302933830054230293

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 KiloPascal1060 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
644720625
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03830054237742StarWalkerM031-3A/2 PICO Pro2025-10-20
03830054238176LightWalker MaxM021-5AF/1 Max2025-07-11
03830054230927SkyPulseM321-A2024-10-04
03830054230934SkyPulseM321-B2024-10-04
03830054230385AvalancheLaseM071-2F/XP2024-09-20
03830054237629TimeWalker ATM021-5AF/12024-09-19
03830054237636TimeWalker ST-EM002-6A/22024-09-19
03830054237681LightWalker AT SM021-5AF/1 S2024-09-19
03830054237698LightWalker ST-E PROM002-6A/2 PRO2024-09-19
03830054237704LightWalker ST-E ADVANCEDM002-6A/2 ADVANCED2024-09-19
03830054230866XPulse1064 nm2022-12-21
03830054230361AvalancheLaseM071-2F/LXP2023-03-07
03830054230378AvalancheLaseM071-2F/LX2023-03-07
03830054230507TimeWalker ATM021-5AF/12021-12-01
03830054230514TimeWalker ST-EM002-6A/22021-12-01
03830054230392SkyPulseM321-A2020-06-23
03830054230408SkyPulseM321-B2020-06-23
03830054230101SP DynamisM021-4AF/32016-09-19
03830054230118XP DynamisM001-12F2016-09-19
03830054230125XS DynamisM002-2A2016-09-19

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