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Tixel 2 System

by Novoxel Ltd

510(k) K223033

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223033↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223033 Date21 Jun 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K223033 decided 21 Jun 2023 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
GEI
FDA applicant
Novoxel , Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K223033

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K223033
UDI-DISize and differences
Tixel 2 TXLD0012
NOVOXEL LTD
TXLD001207290117524039 —On the market

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

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