Tixel Handpiece

Basic Information

• Brand Name: Tixel Handpiece
• Primary DI: 07290117524053
• Version / Model: MSH00001
• Company Name: NOVOXEL LTD
• Labeler DUNS: 600275858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-14
• Public Version: 1
• Public Version Date: 2021-11-22
• Public Version Status: New
• Public Device Record Key: 8de120ee-d3ef-4f05-9139-9056024c99b2

Device Description

To be used with Tixel C Model MSTX0002

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: 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
62363	Thermo-mechanical skin surface treatment system handpiece	A mains electricity (AC-powered), hand-held device intended to apply repetitive pulsed heat and mechanical force, via an attached heat-conductive handpiece tip, to the skin surface for ablative and/or non-ablative treatment of various skin conditions (e.g., pigmentation, scarring, actinic keratosis, acne, wrinkles) during skin resurfacing and rejuvenation procedures. It is an electronic device with an activation switch designed to connect to the system’s control unit; a handpiece tip may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290117524053	GS1

Premarket Submissions

Submission Number	Supplement Number
K202988	000