XPulse

GUDID 03830054230866

XPulse® diode lasers are the modern and professional choice for treating soft tissues, haemostasis and for disinfection. With a broad range of clinical presets, handpieces and multiple pulse modalities, XPulse® allows practitioners to perform optimized treatments, with superior battery or plug in operation, for ultimate portability. The device and its accessories are intended to be used in the fields of dentistry, dermatology, surgery and pain management.

FOTONA d.o.o.

General/multiple surgical solid-state laser system
Primary Device ID03830054230866
NIH Device Record Key27c5a045-bfae-4f9f-97df-e27ba489d892
Commercial Distribution StatusIn Commercial Distribution
Brand NameXPulse
Version Model Number1064 nm
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

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal
Handling Environment TemperatureBetween 18 Degrees Celsius and 28 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 75 KiloPascal and 108 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103830054230866 [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 Number2
Public Version Date2024-09-23
Device Publish Date2022-12-21

Devices Manufactured by FOTONA d.o.o.

03830054230927 - SkyPulse2024-10-14 The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser P
03830054230934 - SkyPulse2024-10-14 The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser P
03830054230385 - AvalancheLase2024-09-30 The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are
03830054237629 - TimeWalker AT2024-09-27 The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It co
03830054237636 - TimeWalker ST-E2024-09-27 The devices of Fotona LightWalker Laser System Family are based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It co
03830054237681 - LightWalker AT S2024-09-27 The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two f
03830054237698 - LightWalker ST-E PRO2024-09-27 The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two f
03830054237704 - LightWalker ST-E ADVANCED2024-09-27 The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two f

Trademark Results [XPulse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XPULSE
XPULSE
87120967 5563416 Live/Registered
Schlumberger Canada Limited
2016-07-29
XPULSE
XPULSE
86366109 4774224 Live/Registered
Laverlam International Corporation
2014-08-13
XPULSE
XPULSE
79099034 4208273 Live/Registered
FOTONA d.o.o.
2011-05-30
XPULSE
XPULSE
78937678 not registered Dead/Abandoned
Sport Design Studio SDS inc.
2006-07-26
XPULSE
XPULSE
77180738 3669885 Dead/Cancelled
Impact Sports Technologies, Inc.
2007-05-14

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