Fotona XP Max

GUDID 03830054230163

The Fotona XP Max (DualisXP Plus II) laser system incorporates a treatment laser that operates in the invisible near-infrared range of the electromagnetic spectrum, and an aiming beam laser that operates in the visible range. The Variable Square Pulse (VSP) Technology implemented in the laser systems allows ultimate control of laser energy and laser pulse length. The Fotona XP Max (DualisXP Plus II) laser system incorporates the following laser sources: · A long-pulse Nd:YAG laser, with a wavelength of 1064 nm · An aiming beam diode laser, with a wavelength of 650 nm The Fotona XP MAX (DualisXP Plus II) Nd:YAG laser system and its accessories is indicated for use in surgical and aesthetic applications requiring the selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology.

FOTONA d.o.o.

General/multiple surgical solid-state laser system

• Primary Device ID: 03830054230163
• NIH Device Record Key: 80f62977-9ad0-4600-8023-036b0f3a1543
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fotona XP Max
• Version Model Number: M001-12F
• 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

• 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	03830054230163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050293

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: 2020-02-06
• Device Publish Date: 2016-09-19

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