# K192623: LipiFlow Thermal Pulsation System

- Pathway: 510(k) (Special)
- Applicant: Tearscience, Inc.
- Decided: Oct 22, 2019 after 29 days
- Product code: ORZ (Eyelid Thermal Pulsation System)
- Device class: 2
- Regulation: 21 CFR 886.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN100017 (2011). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161357: LipiFlow Thermal Pulsation System, Tearscience, Inc. (2016) Summary page 4.

## Most influential descendants
- K240512: Tixel i (TXLI0001) (2024), 0 descendants of its own

## 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/K192623
Methodology: https://510kreport.com/methodology