FDA Product Code ORZ: Eyelid Thermal Pulsation System
Therapeutic Application Of Heat And Massage To The Eyelids.
Leading manufacturers include Sight Sciences, Inc., Tearscience, Inc. and Tear Film Innovations, Inc..
12
Total
11
Cleared
166d
Avg days
2011
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
245d
recently vs 139d historically
FDA 510(k) Cleared Eyelid Thermal Pulsation System Devices (Product Code ORZ)
12 devices
Cleared
Apr 27, 2026
TearCare MGX System
Sight Sciences, Inc.
Ophthalmic
269d
Cleared
Apr 15, 2025
TearCare MGX System
Sight Sciences, Inc.
Ophthalmic
211d
Cleared
Nov 04, 2024
Tixel i (TXLI0001)
Novoxel , Ltd.
Ophthalmic
256d
Cleared
Dec 27, 2023
TearCare MGX System
Sight Sciences, Inc.
Ophthalmic
254d
Cleared
Dec 21, 2021
TearCare System
Sight Sciences, Inc.
Ophthalmic
90d
Cleared
May 21, 2020
Systane iLux2
Tear Film Innovations, Inc.
Ophthalmic
93d
Cleared
Oct 22, 2019
LipiFlow Thermal Pulsation System
Tearscience, Inc.
Ophthalmic
29d
About Product Code ORZ - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code ORZ since 2011, with 11 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 3 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 245 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 →