StarWalker

GUDID 03830054230354

The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmented and vascular lesions, surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue, and incision/excision, ablation and vaporization of soft tissue in general dermatology.

FOTONA d.o.o.

Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system Dermatological frequency-doubled solid-state laser system
Primary Device ID03830054230354
NIH Device Record Keyb38019b0-a435-4dc5-959c-583dd49175b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameStarWalker
Version Model NumberM031-3A/2 QX
Company DUNS644720625
Company NameFOTONA d.o.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103830054230354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-08-24
Device Publish Date2017-08-29

On-Brand Devices [StarWalker]

03830054230484The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, trea
03830054230354The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tat
03830054230330The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tat

Trademark Results [StarWalker]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STARWALKER
STARWALKER
98016387 not registered Live/Pending
Ashish Kamath
2023-05-26
STARWALKER
STARWALKER
86858693 5127048 Live/Registered
Montblanc-Simplo GmbH
2015-12-28
STARWALKER
STARWALKER
86703357 4908320 Live/Registered
Cheng Ruzhong
2015-07-24
STARWALKER
STARWALKER
79163686 4911151 Live/Registered
Montblanc-Simplo GmbH
2015-03-03
STARWALKER
STARWALKER
79122454 4464409 Live/Registered
FOTONA d.o.o.
2012-10-26
STARWALKER
STARWALKER
79022332 3294203 Dead/Cancelled
Montblanc-Simplo GmbH
2006-01-17
STARWALKER
STARWALKER
79006883 3038120 Live/Registered
MONTBLANC - SIMPLO GmbH.
2004-07-23
STARWALKER
STARWALKER
78181734 2759073 Live/Registered
Montblanc-Simplo GmbH
2002-11-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.