Fotona XP Focus

GUDID 03830054230224

The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which is available in a table-top version or mobile version with an undercarriage that provides additional storage space. All laser systems within the family incorporate a treatment laser that operates in the invisible, near-infrared range of the electromagnetic spectrum and an aiming laser that operates in the visible range. XP Focus family laser systems incorporate: · A Nd:YAG laser source operating at a wavelength of 1064 nm in PULSE and Quasi Continuous Wave (QCW) mode of operation. · An aiming semiconductor diode laser operating at a wavelength of 650 nm. The Variable Square Pulse (VSP) Technology incorporated in the laser systems provides control of laser energy and laser pulse length.

FOTONA d.o.o.

General/multiple surgical solid-state laser system

• Primary Device ID: 03830054230224
• NIH Device Record Key: 08c33bdd-5ca3-456f-ace7-978e3bba250a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fotona XP Focus
• Version Model Number: M001-14F 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830054230224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090126

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

On-Brand Devices [Fotona XP Focus]

• 03830054230224: The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which i
• 03830054230170: The Fotona XP Focus family of laser systems consists of the XP-2 Focus and the XP Focus, which i