Ellipse 9SYS7751

GUDID 05713530000178

Multi-modality skin surface treatment system: Intense Pulsed Light (IPL) and Laser device.

Ellipse A/S

Multi-modality skin surface treatment system

• Primary Device ID: 05713530000178
• NIH Device Record Key: db543431-5871-495d-8164-5b36b2f7bcd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ellipse
• Version Model Number: Nordlys
• Catalog Number: 9SYS7751
• 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: ok@ellipse.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713530000178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150907

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-22

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).