De Novo · Granted
GrantedLipflow Thermal Pulsation System (Formerly Manual Mini System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tearscience, Inc. · ORZ Eyelid Thermal Pulsation System
Granted on Jun 28, 2011 as a new device type through De Novo after a 323-day review. 12 later devices descend from it.
- Decided
- Jun 28, 2011
- Review
- 323 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- None
12 later devices descend from it, 3 citing it directly.
- This deviceDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- Descendant · cites it directly · 11 of its ownK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- Descendant · cites it directly · 10 of its ownK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · Recalled
- Descendant · cites it directly · 7 of its ownK161357 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK213045 TearCare SystemSight Sciences, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK231084 TearCare MGX SystemSight Sciences, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K112704Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · cites it directly11descendants
- K133127Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · cites it directly10descendants
- K161357LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016 · cites it directly7descendants
- K213045TearCare SystemSight Sciences, Inc. · 2021 · 2 generations on5descendants
- K231084TearCare MGX SystemSight Sciences, Inc. · 2023 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| +1 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| +1 | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | 2 |
| +1 | K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016 | 1 |
| +2 | K213045 | TearCare System | Sight Sciences, Inc. | 2021 | — |
| +3 | K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (12)
See all 123 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K112704 (Tearscience, Inc., 2011) has gone furthest, with 11 descendants of its own.
How does its category compare?
All ORZ devicesORZ Eyelid Thermal Pulsation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 | — |
https://510kreport.com/device/DEN100017 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN100017
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026