# K213045: TearCare System

- Pathway: 510(k) (Traditional)
- Applicant: Sight Sciences, Inc.
- Decided: Dec 21, 2021 after 90 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.
5 later devices descend from it; 1 cites it directly.
0 of 10 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
- 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
- K262479: TearCare System (2026), 0 descendants of its own
- K240512: Tixel i (TXLI0001) (2024), 0 descendants of its own

## Indications for use
The TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

Source page: https://510kreport.com/device/K213045
Methodology: https://510kreport.com/methodology