RFUTE Handpiece Upgrade

Basic Information

• Brand Name: RFUTE Handpiece Upgrade
• Primary DI: 00810096330055
• Version / Model: RFUTE Handpiece Upgrade
• Company Name: Lumenis Be, Inc.
• Labeler DUNS: 118292380
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-13
• Public Version: 2
• Public Version Date: 2022-11-03
• Public Version Status: Update
• Public Device Record Key: d40bf94b-48e3-4cae-a338-6764f12a3399
• Distribution End Date: 2022-10-31

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45048	Radio-frequency skin contouring system applicator tip	A removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810096330055	GS1

Premarket Submissions

Submission Number	Supplement Number
K220124	000