510(k) · Cleared
ClearedTixel i (TXLI0001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novoxel, Ltd. · ORZ Eyelid Thermal Pulsation System
Cleared on Nov 4, 2024 as substantially equivalent to K192623 (Tearscience, Inc., 2019) and 2 other predicates after a 256-day review. Its family tree reaches back 6 generations to 2011.
- Decided
- Nov 4, 2024
- Review
- 256 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to DEN100017 (2011). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- 5 generations backK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- 4 generations backK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · Recalled
- 3 generations backK161357 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016 · Recalled
- 2 generations backK213045 TearCare SystemSight Sciences, Inc. · 2021
- 1 generation backK231084 TearCare MGX SystemSight Sciences, Inc. · 2023
- This deviceK240512 Tixel i (TXLI0001)Novoxel, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| −5 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| −4 | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | 2 |
| −3 | K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016 | 1 |
| −2 | K213045 | TearCare System | Sight Sciences, Inc. | 2021 | — |
| −1 | K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 | — |
| 0 (this device) | K240512 | Tixel i (TXLI0001) | Novoxel, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ORZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ORZ device
- #1 K252409 TearCare MGX Systemscore 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192623 | LipiFlow Thermal Pulsation SystemSummary page 5…lass 2 Product Code: ORZ III. Predicate Device and Reference Devices Predicate Devices • LipiFlow Thermal Pulsation System by TearScience (K192623) – Primary Predicate • iLux by Tear Film Innovation (K172645) • TearCare MGX by Sight Sciences (K231084) Refer… | 2019 |
| * | K172645 | iLux Instrument, iLux DisposableSummary page 5…Reference Devices Predicate Devices • LipiFlow Thermal Pulsation System by TearScience (K192623) – Primary Predicate • iLux by Tear Film Innovation (K172645) • TearCare MGX by Sight Sciences (K231084) Reference Device • Tixel C by Novoxel (K223033) The Tixel… | 2017 |
| * | K231084 | TearCare MGX SystemSummary page 5…piFlow Thermal Pulsation System by TearScience (K192623) – Primary Predicate • iLux by Tear Film Innovation (K172645) • TearCare MGX by Sight Sciences (K231084) Reference Device • Tixel C by Novoxel (K223033) The Tixel C supports the methods (i.e., an ex vivo study) use… | 2023 |
| † | K223033 | Tixel® 2 System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 8 ancestors have a recall of any class.
How does its category compare?
All ORZ devicesORZ Eyelid Thermal Pulsation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · ORZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ORZ
Too few ORZ 510(k)s in any year since 2007 to give a median.
Recalls per year · ORZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ORZ
1in 2025
MAUDE reports naming product code ORZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 1 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240512: Tixel i (TXLI0001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240512
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026