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 Dec 23, 2013 as substantially equivalent to DEN100017 (Tearscience, Inc., 2011) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 2011. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 23, 2013
- Review
- 84 days
- Class
- Class II
- Product code
- ORZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN100017 (2011). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN100017 Lipflow Thermal Pulsation System (Formerly Manual Mini System)Tearscience, Inc. · 2011
- 1 generation backK112704 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2011 · Recalled
- This deviceK133127 Lipiflow Thermal Pulsation SystemTearscience, Inc. · 2013
- 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
- Descendant · 4 generations on · 2 of its ownK242786 TearCare MGX SystemSight Sciences, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK172645 iLux Instrument, iLux DisposableTear Film Innovations, Inc. · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K242786TearCare MGX SystemSight Sciences, Inc. · 2025 · 4 generations on2descendants
- K172645iLux Instrument, iLux DisposableTear Film Innovations, Inc. · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN100017 | Lipflow Thermal Pulsation System (Formerly Manual Mini System) | Tearscience, Inc. | 2011 | — |
| −1 | K112704 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2011 | 2 |
| 0 (this device) | K133127 | Lipiflow Thermal Pulsation System | Tearscience, Inc. | 2013 | — |
| +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 | — |
| +4 | K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025 | — |
| +1 | K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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) Our reading of the summary gave K093937, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN100017, Lipflow Thermal Pulsation System (Formerly Manual Mini… (Tearscience, Inc.), granted Jun 28, 2011; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2011 |
| * | K112704 | Lipiflow Thermal Pulsation SystemSummary page 1…ble) Class 11 uinder 21 CFR 886.5200 Applicant: TearScience. Inc. Cleared under K! 112704 on December 19, 2011 (corrected letter received ianuary 12, 2012) Clas… | 2011 |
What descends from it? (10)
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. |
| Sep 13, 2016 | Class II | Z-0093-2017 | Device Design | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K161357 (Tearscience, Inc., 2016) has gone furthest, with 7 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. 2013, 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/K133127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133127: 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/K133127
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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