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 Aug 18, 2026 as substantially equivalent to K252409 (Sight Sciences, Inc., 2026) after a 29-day review. Its family tree reaches back 8 generations to 2011.
- Decided
- Aug 18, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN100017 (2011). No later device cites it as a predicate yet.
- Root · 8 generations backDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- 7 generations backK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- 6 generations backK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · Recalled
- 5 generations backK161357 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016 · Recalled
- 4 generations backK213045 TearCare SystemSight Sciences, Inc. · 2021
- 3 generations backK231084 TearCare MGX SystemSight Sciences, Inc. · 2023
- 2 generations backK242786 TearCare MGX SystemSight Sciences, Inc. · 2025
- 1 generation backK252409 TearCare MGX SystemSight Sciences, Inc. · 2026
- This deviceK262479 TearCare SystemSight Sciences, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| −7 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| −6 | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | 2 |
| −5 | K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016 | 1 |
| −4 | K213045 | TearCare System | Sight Sciences, Inc. | 2021 | — |
| −3 | K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 | — |
| −2 | K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025 | — |
| −1 | K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026 | — |
| 0 (this device) | K262479 | TearCare System | Sight Sciences, Inc. | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K252409 | TearCare MGX SystemSummary page 5…ORZ Predicate Device Device Name: TearCare MGX System 510(k) Holder: Sight Sciences, Inc. 510(k) Number: K252409 Clearance Date: April 27, 2026 Indications for Use The Sight Sciences TearCare® System is a thermal-act… | 2026 |
| † | K231084 | TearCare MGX System | 2023 |
| † | K213045 | TearCare System | 2021 |
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 15 years and passes through 2 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. 2026, 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 Sight Sciences TearCare® System is a thermal-activated gland expression therapy that improves meibomian gland function 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/K262479 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262479: TearCare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262479
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026