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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2022 | Sight Sciences, Inc. TearCare version 1.0 SmartHubs Open, Classified |
ORZ | None listed |
| Mar 22, 2017 | Tearscience, Inc LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile Terminated |
ORZ | K112704 K133127 +1 |
| Oct 17, 2016 | Tearscience, Inc LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100
The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the applica Terminated |
ORZ | K112704 K133127 |
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