NAFR Tips

GUDID 00810096330048

Lumenis Be, Inc.

Multi-modality skin surface treatment system

• Primary Device ID: 00810096330048
• NIH Device Record Key: 529bed62-7720-472d-9774-cf5ee486b687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAFR Tips
• Version Model Number: NAFR Tips
• Company DUNS: 118292380
• Company Name: Lumenis Be, Inc.
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00810096330048 [Unit of Use]
GS1	10810096330045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211979

FDA Product Code

• ONG: Powered Laser Surgical Instrument With Microbeam\Fractional Output

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: 2022-09-21
• Device Publish Date: 2022-09-13

Devices Manufactured by Lumenis Be, Inc.

• 00810096330000 - Selecta Duet™: 2023-05-22
• 00810096330017 - Digital Duet™: 2023-05-22
• 00810096330024 - Smart-V Illumination Add-on: 2023-05-22
• 00810096330062 - Smart532: 2023-04-10
• 00810096330079 - Array LaserLink: 2023-04-10
• 00810096330086 - Vision One: 2023-04-10
• 00810096330093 - Vision One: 2023-04-10
• 00810096330109 - Vision One: 2023-04-10