SkyPulse

GUDID 03830054230392

The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.

FOTONA d.o.o.

Dental solid-state laser system

• Primary Device ID: 03830054230392
• NIH Device Record Key: e6efdcc6-7e26-4aef-bce7-9c180877f9e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkyPulse
• Version Model Number: M321-A
• Company DUNS: 644720625
• Company Name: FOTONA d.o.o.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	03830054230392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193656

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [SkyPulse]

• 03830054230408: The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modu
• 03830054230392: The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modu