# K223033: Tixel® 2 System

- Pathway: 510(k) (Traditional)
- Applicant: Novoxel, Ltd.
- Decided: Jun 21, 2023 after 265 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 227 ancestors in all.
No later device cites it as a predicate yet.
0 of 228 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202988: Tixel System, Novoxel, Ltd. (2021) Summary page 4.

## Indications for use
The Tixel® 2 System is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K223033
Methodology: https://510kreport.com/methodology