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Tixel 2 System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223033

by Novoxel Ltd

Identifiers

510(k) Number
K223033 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tixel 2 System is a thermo-mechanical skin resurfacing device (Product Code: GEI) designed for controlled ablation and resurfacing of the skin. It employs a proprietary mechanism to address periorbital wrinkles and other dermatological indications requiring precise tissue modification.

This device is supplied as a reusable system with disposable consumables, intended for use in clinical settings by trained professionals. It has received FDA 510(k) clearance under the Traditional pathway (K223033) and complies with MDR requirements. No specific MRI safety classification or sterility standards are noted in the submitted data.

Frequently asked questions

What types of skin concerns is the Tixel® 2 System specifically designed to address, and how does it work?

The Tixel® 2 System is designed for controlled ablation and resurfacing of the skin, particularly targeting periorbital wrinkles and other dermatological conditions requiring precise tissue modification. It uses a thermo-mechanical mechanism to gently resurface the skin, promoting renewal while minimizing damage to surrounding tissues. This makes it suitable for professionals seeking a non-invasive approach to skin rejuvenation.

Is the Tixel® 2 System reusable, and if so, what disposable components are included in the system?

Yes, the Tixel® 2 System itself is reusable, but it requires disposable consumables for each procedure. These consumables are essential for maintaining sterility and ensuring safe, single-use contact with the patient’s skin. The exact components are not detailed in the provided data, but the system is designed for clinical settings where trained professionals can manage these consumables properly.

How is the Tixel® 2 System regulated, and what pathway was used for its FDA clearance?

The Tixel® 2 System received FDA clearance under the Traditional 510(k) pathway, specifically classified under Product Code GEI (General, Plastic Surgery). It was determined to be substantially equivalent to a legally marketed predicate device. Additionally, the system complies with the Medical Device Regulation (MDR) requirements, ensuring it meets both U.S. and EU regulatory standards.

Are there any specific storage requirements for the Tixel® 2 System, and how should it be handled between uses?

The provided data does not specify sterility standards or detailed storage instructions for the reusable Tixel® 2 System. However, as a reusable medical device intended for clinical use, it should be cleaned, disinfected, and stored according to manufacturer guidelines to prevent contamination and ensure proper functionality. Always follow Novoxel Ltd.’s instructions for maintenance and handling.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Novoxel , Ltd. FDA 510 (k) Products - Latest 2024, PDF Janice Hogan Partner Hogan Lovells US LLP Trade/Device Name: Tixel® 2 ..., Tixel® 2 System (K223033) — FDA 510 (k) | Innolitics, Tixel: Does the Thermo-Mechanical Resurfacing Device Work? FDA ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Novoxel Ltd
FDA Applicant
Novoxel , Ltd.

Sources (2)

  • FDA 510(k) K223033 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026