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 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 |
Operating and Storage Conditions
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03830054230866 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221712
FDA Product Code
| GEX | Powered Laser Surgical Instrument |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-09-23 |
| Device Publish Date | 2022-12-21 |
Devices Manufactured by FOTONA d.o.o.
| 03830054238176 - LightWalker Max | 2025-07-21 The Fotona LightWalker Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. It combines two f |
| 03830054238138 - QuantumStar, StarFormer | 2025-06-20 It is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators |
| 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 |
Trademark Results [XPulse]
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 |
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