510(k) · Cleared
Recalled · Class II · 2017LipiFlow Thermal Pulsation 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
Cleared on Nov 4, 2016 as substantially equivalent to DEN100017 (Tearscience, Inc., 2011) and 2 other predicates after a 172-day review. Its family tree reaches back 3 generations to 2011. 7 later devices descend from it. It has been recalled once.
- Decided
- Nov 4, 2016
- Review
- 172 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN100017 (2011). 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- 2 generations backK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- 1 generation backK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013 · Recalled
- This deviceK161357 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK213045 TearCare SystemSight Sciences, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK231084 TearCare MGX SystemSight Sciences, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK242786 TearCare MGX SystemSight Sciences, Inc. · 2025
- Descendant · 4 generations on · 1 of its ownK252409 TearCare MGX SystemSight Sciences, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK192623 LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K213045TearCare SystemSight Sciences, Inc. · 2021 · cites it directly5descendants
- K231084TearCare MGX SystemSight Sciences, Inc. · 2023 · 2 generations on4descendants
- K242786TearCare MGX SystemSight Sciences, Inc. · 2025 · 3 generations on2descendants
- K252409TearCare MGX SystemSight Sciences, Inc. · 2026 · 4 generations on1descendant
- K192623LipiFlow Thermal Pulsation SystemTearscience, Inc. · 2019 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| −2 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| −1 | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | 2 |
| 0 (this device) | K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016 | — |
| +1 | K213045 | TearCare System | Sight Sciences, Inc. | 2021 | — |
| +2 | K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023 | — |
| +3 | K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025 | — |
| +4 | K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026 | — |
| +1 | K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 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 16.0 · 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 |
|---|---|---|---|
| * | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System)Summary page 4…n System Class II under 21 CFR 886.5200 Applicant: TearScience, Inc. Cleared under DEN100017 on June 28, 2011 Handheld Control System Model LFH-1000 and Dispo… | 2011 |
| * | K112704 | Lipiflow Thermal Pulsation SystemSummary page 4… Handheld Control System Model LFH-1000 and Disposable Model LFD-1000 Cleared under K112704 on December 19, 2011 (corrected letter received January 12, 2012) C… | 2011 |
| * | K133127 | Lipiflow Thermal Pulsation SystemSummary page 4… Console Model LFTP-1000 and Activator (Disposable)Model LFD-1000 Cleared under K133127 on December 23, 2013 Console Model LFTP-1000 and Activator (Dispo… | 2013 |
What descends from it? (7)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2017 | Class II | Z-1535-2017 | Labeling Change Control | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K213045 (Sight Sciences, Inc., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate DEN100017.
How does its category compare?
All ORZ devicesORZ Eyelid Thermal Pulsation System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 LipiFlow® Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161357: LipiFlow Thermal Pulsation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161357
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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