Titan XL

Basic Information

• Brand Name: Titan XL
• Primary DI: 00816722022912
• Version / Model: Titan XL
• Company Name: CUTERA, INC.
• Labeler DUNS: 041071643
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-12-01
• Public Version Status: Update
• Public Device Record Key: 118d212f-8683-48e9-8ef5-8e86baf8e6b2

Device Description

Titan XL IPL Handpiece

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
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45212	Multi-modality skin contouring system applicator, infrared light	A device that is part of a skin contouring system that is used to apply an energy consisting of infrared light to the skin of a patient to temporarily minimize the manifestation of cellulite, loose or wrinkled skin. This device is connected to an energy-producing generator and is moved across a patient's skin by a practitioner or staff for treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816722022912	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]