StarWalker

Primary DI
03830054230330
Brand
StarWalker
Company
FOTONA d.o.o.
Model
M031-3A/2 MAQX
Device description
The Fotona StarWalker Laser System Family is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavitycontaining the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linearcrystal. The Nd:YAG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using abeamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAGbeam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam intoa 585 nm or a 650 nm wavelength, correspondingly.
Published
2017-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171227000
K202172000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171227000StarWalkerFotona D.O.O.2017-08-18GEX
K202172000StarWalkerFotona D.O.O.2020-11-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830054230330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830054230330038300542303303830054230330

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological frequency-doubled 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 to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm); it may include additional glass/crystal rods and pumping options to achieve additional laser wavelengths. It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Atmospheric Pressure700 Percent (%) Relative Humidity1060 Percent (%) Relative Humidity
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius50 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
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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
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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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