Frax 1550

GUDID 05713530000291

Ellipse A/S

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 05713530000291
• NIH Device Record Key: eede33e3-ee7f-4a85-aa97-bba903e5849f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Frax 1550
• Version Model Number: 9APP7829
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713530000291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161162

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

On-Brand Devices [Frax 1550]

• 05713530000291: 9APP7829
• 05713530000277: 9APP7829