Panels › Ophthalmic › Product code ORZ · Class 2
Eyelid Thermal Pulsation System
Regulation 886.5200
2510(k)s in 12 months (13 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in ORZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Tearscience, Inc. | 5 | 2 |
| Sight Sciences, Inc. | 5 | 1 |
| Tear Film Innovations, Inc. | 2 | 0 |
| Novoxel , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2026 | K262479 | TearCare System Sight Sciences, Inc. | ORZ |
| Apr 27, 2026 | K252409 | TearCare MGX System Sight Sciences, Inc. | ORZ |
| Apr 15, 2025 | K242786 | TearCare MGX System Sight Sciences, Inc. | ORZ |
| Nov 4, 2024 | K240512 | Tixel i (TXLI0001) Novoxel , Ltd., IL | ORZ |
| Dec 27, 2023 | K231084 | TearCare MGX System Sight Sciences, Inc. | ORZ |
| Dec 21, 2021 | K213045 | TearCare System Sight Sciences, Inc. | ORZ |
| May 21, 2020 | K200400 | Systane iLux2 Tear Film Innovations, Inc. | ORZ |
| Oct 22, 2019 | K192623 | LipiFlow Thermal Pulsation System Tearscience, Inc. | ORZ |
| Dec 26, 2017 | K172645 | iLux Instrument, iLux Disposable Tear Film Innovations, Inc. | ORZ |
| Nov 4, 2016 | K161357 | LipiFlow Thermal Pulsation System Tearscience, Inc. | ORZ |
| Dec 23, 2013 | K133127 | LIPIFLOW THERMAL PULSATION SYSTEM Tearscience, Inc. | ORZ |
| Dec 19, 2011 | K112704 | LIPIFLOW THERMAL PULSATION SYSTEM Tearscience, Inc. | ORZ |
| Jun 28, 2011 | DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) Tearscience, Inc. | ORZ |
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