ORZ · Class II · 21 CFR 886.5200

FDA Product Code ORZ: Eyelid Thermal Pulsation System

Therapeutic Application Of Heat And Massage To The Eyelids.

Leading manufacturers include Tearscience, Inc., Sight Sciences, Inc. and Tear Film Innovations, Inc..

13
Total
12
Cleared
155d
Avg days
2011
Since
Growing category - 4 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 191d recently vs 139d historically

FDA 510(k) Cleared Eyelid Thermal Pulsation System Devices (Product Code ORZ)

13 devices
1–13 of 13
Cleared Aug 18, 2026
TearCare System
K262479
Sight Sciences, Inc.
Ophthalmic · 29d
Cleared Apr 27, 2026
TearCare MGX System
K252409
Sight Sciences, Inc.
Ophthalmic · 269d
Cleared Apr 15, 2025
TearCare MGX System
K242786
Sight Sciences, Inc.
Ophthalmic · 211d
Cleared Nov 04, 2024
Tixel i (TXLI0001)
K240512
Novoxel , Ltd.
Ophthalmic · 256d
Cleared Dec 27, 2023
TearCare MGX System
K231084
Sight Sciences, Inc.
Ophthalmic · 254d
Cleared Dec 21, 2021
TearCare System
K213045
Sight Sciences, Inc.
Ophthalmic · 90d
Cleared May 21, 2020
Systane iLux2
K200400
Tear Film Innovations, Inc.
Ophthalmic · 93d
Cleared Oct 22, 2019
LipiFlow Thermal Pulsation System
K192623
Tearscience, Inc.
Ophthalmic · 29d
Cleared Dec 26, 2017
iLux Instrument, iLux Disposable
K172645
Tear Film Innovations, Inc.
Ophthalmic · 116d
Cleared Nov 04, 2016
LipiFlow Thermal Pulsation System
K161357
Tearscience, Inc.
Ophthalmic · 172d
Cleared Dec 23, 2013
LIPIFLOW THERMAL PULSATION SYSTEM
K133127
Tearscience, Inc.
Ophthalmic · 84d
Cleared Dec 19, 2011
LIPIFLOW THERMAL PULSATION SYSTEM
K112704
Tearscience, Inc.
Ophthalmic · 94d
Not Cleared Jun 28, 2011
LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
DEN100017
Tearscience, Inc.
Ophthalmic · 323d

About Product Code ORZ - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code ORZ since 2011, with 12 receiving FDA clearance (average review time: 155 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - ORZ Product Code

Recent submissions under ORZ have taken an average of 191 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.

ORZ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →