# K112704: Lipiflow Thermal Pulsation System

- Pathway: 510(k) (Traditional)
- Applicant: Tearscience, Inc.
- Decided: Dec 19, 2011 after 94 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN100017 (2011). 1 ancestor in all.
11 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN100017: Lipflow Thermal Pulsation System (Formerly Manual Mini System), Tearscience, Inc. (2011). Our OCR of the scanned summary read 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.

## Most influential descendants
- K133127: Lipiflow Thermal Pulsation System (2013), 10 descendants of its own
- K161357: LipiFlow Thermal Pulsation System (2016), 7 descendants of its own
- K213045: TearCare System (2021), 5 descendants of its own
- K231084: TearCare MGX System (2023), 4 descendants of its own
- K242786: TearCare MGX System (2025), 2 descendants of its own

## Recalls of this device
- Jan 30, 2017 · Class II · Z-1535-2017: 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: Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.

## Indications for use
The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic condictions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

Source page: https://510kreport.com/device/K112704
Methodology: https://510kreport.com/methodology