# K161357: LipiFlow Thermal Pulsation System

- Pathway: 510(k) (Special)
- Applicant: Tearscience, Inc.
- Decided: Nov 4, 2016 after 172 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN100017 (2011). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 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) Summary page 4.
- K112704: Lipiflow Thermal Pulsation System, Tearscience, Inc. (2011) Summary page 4.
- K133127: Lipiflow Thermal Pulsation System, Tearscience, Inc. (2013) Summary page 4.

## Most influential descendants
- 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
- K252409: TearCare MGX System (2026), 1 descendant of its own
- K192623: LipiFlow Thermal Pulsation System (2019), 1 descendant 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.

## 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 conditions 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/K161357
Methodology: https://510kreport.com/methodology