510(k) · Cleared
ClearedTearCare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sight Sciences, Inc. · ORZ Eyelid Thermal Pulsation System
Cleared on Dec 21, 2021 as substantially equivalent to K161357 (Tearscience, Inc., 2016) after a 90-day review. Its family tree reaches back 4 generations to 2011. 5 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN100017 (2011). 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- 3 generations backK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- 2 generations backK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · Recalled
- 1 generation backK161357 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016 · Recalled
- This deviceK213045 TearCare SystemSight Sciences, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK231084 TearCare MGX SystemSight Sciences, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK242786 TearCare MGX SystemSight Sciences, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK252409 TearCare MGX SystemSight Sciences, Inc. · 2026
- Descendant · 4 generations on · 0 of its ownK262479 TearCare SystemSight Sciences, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK240512 Tixel i (TXLI0001)Novoxel, Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K231084TearCare MGX SystemSight Sciences, Inc. · 2023 · cites it directly4descendants
- K242786TearCare MGX SystemSight Sciences, Inc. · 2025 · 2 generations on2descendants
- K252409TearCare MGX SystemSight Sciences, Inc. · 2026 · 3 generations on1descendant
- K262479TearCare SystemSight Sciences, Inc. · 2026 · 4 generations on0descendants
- K240512Tixel i (TXLI0001)Novoxel, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| −3 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| −2 | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | 2 |
| −1 | K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016 | 1 |
| 0 (this device) | K213045 | TearCare System | Sight Sciences, Inc. | 2021 | — |
| +1 | K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 | — |
| +2 | K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025 | — |
| +3 | K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026 | — |
| +4 | K262479 | TearCare System | Sight Sciences, Inc. | 2026 | — |
| +2 | K240512 | Tixel i (TXLI0001) | Novoxel, Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 16.1 · 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? (1)
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 |
|---|---|---|---|
| * | K161357 | LipiFlow Thermal Pulsation SystemSummary page 4…LipiFlow® Thermal Pulsation System 510(k) Holder: Johnson and Johnson (formerly TearScience, Inc.) 510(k) Number: K161357 Clearance Date: November 4, 2016 Indications for Use The TearCare® System is intended for the application of… | 2016 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231084 | TearCare MGX System | 2023 | 4 |
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 10 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K231084 (Sight Sciences, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K161357.
How does its category compare?
All ORZ devicesORZ Eyelid Thermal Pulsation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213045 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213045: TearCare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213045
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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