Tixel 2

Basic Information

• Brand Name: Tixel 2
• Primary DI: 07290117524039
• Version / Model: TXLD0012
• Company Name: NOVOXEL LTD
• Labeler DUNS: 600275858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-23
• Public Version: 1
• Public Version Date: 2024-05-31
• Public Version Status: New
• Public Device Record Key: 62a9c0d5-222c-4c9c-91a4-893bf51fcb3a

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

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
62362	Thermo-mechanical skin surface treatment system	A mains electricity (AC-powered) portable assembly of devices intended to be used for skin resurfacing and rejuvenation via application of pulsed thermal and mechanical energy (i.e., it does not emit radiation such as laser or radio-frequency energy) on the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles). It consists of a control/display unit, a handpiece, and a removable heat-conductive handpiece tip made of metal, typically with small pointed pins designed to make repeated fractional contact with the skin surface.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117524039	GS1

Premarket Submissions

Submission Number	Supplement Number
K223033	000