Primary Device ID | 03830054230866 |
NIH Device Record Key | 27c5a045-bfae-4f9f-97df-e27ba489d892 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XPulse |
Version Model Number | 1064 nm |
Company DUNS | 644720625 |
Company Name | FOTONA d.o.o. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Handling Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 75 KiloPascal and 108 KiloPascal |
Device Issuing Agency | Device ID |
---|---|
GS1 | 03830054230866 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-09-23 |
Device Publish Date | 2022-12-21 |
03830054230927 - SkyPulse | 2024-10-14 The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser P |
03830054230934 - SkyPulse | 2024-10-14 The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser P |
03830054230385 - AvalancheLase | 2024-09-30 The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are |
03830054237629 - TimeWalker AT | 2024-09-27 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-E | 2024-09-27 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 S | 2024-09-27 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 PRO | 2024-09-27 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 ADVANCED | 2024-09-27 The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two f |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XPULSE 87120967 5563416 Live/Registered |
Schlumberger Canada Limited 2016-07-29 |
XPULSE 86366109 4774224 Live/Registered |
Laverlam International Corporation 2014-08-13 |
XPULSE 79099034 4208273 Live/Registered |
FOTONA d.o.o. 2011-05-30 |
XPULSE 78937678 not registered Dead/Abandoned |
Sport Design Studio SDS inc. 2006-07-26 |
XPULSE 77180738 3669885 Dead/Cancelled |
Impact Sports Technologies, Inc. 2007-05-14 |