# K240512: Tixel i (TXLI0001)

- Pathway: 510(k) (Traditional)
- Applicant: Novoxel, Ltd.
- Decided: Nov 4, 2024 after 256 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN100017 (2011). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192623: LipiFlow Thermal Pulsation System, Tearscience, Inc. (2019) Summary page 5.
- K172645: iLux Instrument, iLux Disposable, Tear Film Innovations, Inc. (2017) Summary page 5.
- K231084: TearCare MGX System, Sight Sciences, Inc. (2023) Summary page 5.

## Indications for use
The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

Source page: https://510kreport.com/device/K240512
Methodology: https://510kreport.com/methodology