Fotona QX Max

GUDID 03830054230064

The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range of the electromagnetic spectrum. Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length. The Fotona QX MAX 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.

General/multiple surgical frequency-doubled solid-state laser system

• Primary Device ID: 03830054230064
• NIH Device Record Key: 893a2c11-1925-4b8b-9210-b61066aca016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fotona QX Max
• Version Model Number: M031-3A/2
• 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 -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 500 KiloPascal and 1060 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 29 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830054230064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083889

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: 4
• Public Version Date: 2021-08-24
• Device Publish Date: 2016-09-19

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