RFUTE Handpiece Upgrade

GUDID 00810096330055

Lumenis Be, Inc.

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• Primary Device ID: 00810096330055
• NIH Device Record Key: d40bf94b-48e3-4cae-a338-6764f12a3399
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RFUTE Handpiece Upgrade
• Version Model Number: RFUTE Handpiece Upgrade
• Company DUNS: 118292380
• Company Name: Lumenis Be, Inc.
• 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	00810096330055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220124

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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