SP Dynamis

GUDID 03830054230101

The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as well as an aiming beam laser that operates in the visible range. The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery.

FOTONA d.o.o.

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system
Primary Device ID03830054230101
NIH Device Record Keye2f0a6cd-8cda-428f-8052-d196259e916c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSP Dynamis
Version Model NumberM021-4AF/3
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
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -40 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 29 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103830054230101 [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 Date2020-02-06
Device Publish Date2016-09-19

Devices Manufactured by FOTONA d.o.o.

03830054230361 - AvalancheLase2023-03-15 The device and its accessories are intended to be used in the fields of aesthetics and dermatology.
03830054230378 - AvalancheLase2023-03-15 The device and its accessories are intended to be used in the fields of aesthetics and dermatology.
03830054230507 - TimeWalker AT2021-12-09 The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urolo
03830054230514 - TimeWalker ST-E2021-12-09 The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urolo
03830054230064 - Fotona QX Max2021-08-24 The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range o
03830054230330 - StarWalker2021-08-24 The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmen
03830054230354 - StarWalker2021-08-24 The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmen
03830054230484 - StarWalker2021-02-05 The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, treatment of pigmented lesions and a

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