ORZ

Eyelid Thermal Pulsation System

Product code
ORZ
Device name
Eyelid Thermal Pulsation System
Device class
Class 2
21 CFR
21 CFR 886.5200
Medical specialty
Ophthalmic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
5
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
13 (all years; only the last 3 years are listed here)

FDA classification definition

Therapeutic application of heat and massage to the eyelids.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-18.

NumberDecision dateApplicantDevice nameSummary
K2624792026-08-18Sight Sciences, Inc.TearCare SystemPDF
K2524092026-04-27Sight Sciences, Inc.TearCare MGX SystemPDF
K2427862025-04-15Sight Sciences, Inc.TearCare MGX SystemPDF
K2405122024-11-04Novoxel , Ltd.Tixel i (TXLI0001)PDF
K2310842023-12-27Sight Sciences, Inc.TearCare MGX SystemFDA

4 summaries are archived here for direct download.

Official FDA classification page: ORZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).