# K262479: TearCare System

- Pathway: 510(k) (Special)
- Applicant: Sight Sciences, Inc.
- Decided: Aug 18, 2026 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: 8 generations back to DEN100017 (2011). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252409: TearCare MGX System, Sight Sciences, Inc. (2026) Summary page 5.

## Indications for use
The Sight Sciences TearCare® System is a thermal-activated gland expression therapy that improves meibomian gland function 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/K262479
Methodology: https://510kreport.com/methodology