PL 400

GUDID 05713530000406

Ellipse A/S

Multi-modality skin surface treatment system

• Primary Device ID: 05713530000406
• NIH Device Record Key: a7a5feae-a393-429b-975f-231f2d0966ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PL 400
• Version Model Number: 9APP7749
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713530000406 [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: 1
• Public Version Date: 2021-03-24
• Device Publish Date: 2021-03-16

Devices Manufactured by Ellipse A/S

• 05713530000444 - Ellipse: 2021-10-19 Multi-modality skin surface treatment system: Intense Pulsed Light (IPL).
• 05713530000079 - HRD 645: 2021-03-24
• 05713530000253 - Nd:YAG Nordlys: 2021-03-24
• 05713530000260 - Nd:YAG MultiFlex: 2021-03-24
• 05713530000277 - Frax 1550: 2021-03-24
• 05713530000291 - Frax 1550: 2021-03-24
• 05713530000338 - HRL 600: 2021-03-24
• 05713530000345 - HRL 600: 2021-03-24