Ellipse 9SYS7852

GUDID 05713530000307

System for skin surface treatment by Laser.

Ellipse A/S

Multi-modality skin surface treatment system

• Primary Device ID: 05713530000307
• NIH Device Record Key: f77e8050-ed18-4753-8b92-04aa8f4427d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipse
• Version Model Number: Ydun
• Catalog Number: 9SYS7852
• Company DUNS: 305006145
• Company Name: Ellipse A/S
• 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: true
• 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

Customer Support Contacts

• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com
• Phone: +4545768808
• Email: sales@ellipse.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713530000246 [Previous]
GS1	05713530000307 [Previous]
GS1	05713530000314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180406

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: 2018-10-19
• Device Publish Date: 2018-09-18

On-Brand Devices [Ellipse]

• 05713530000307: System for skin surface treatment by Laser.
• 05713530000246: System for skin surface treatment by fractional Laser.
• 05713530000178: Multi-modality skin surface treatment system: Intense Pulsed Light (IPL) and Laser device.
• 05713530000444: Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).