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Eyelid Thermal Pulsation System
FDA product code ORZ · Class 2 · Ophthalmic
17
Registered devices
37
Adverse events
3
Recalls
12
510(k) clearances
Devices with this code
Tixel i HP — NOVOXEL LTDLIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE — TEARSCIENCE, INC.LIPIFLOW SYSTEM CONSOLE — TEARSCIENCE, INC.Tixel i — NOVOXEL LTDLIPIFLOW SYSTEM ACTIVATOR II CABLE KIT — TEARSCIENCE, INC.TearCare MGX System - TearCare MGX SmartLids — Sight Sciences, Inc.TearCare System - TearCare SmartLids — Sight Sciences, Inc.TEARSCIENCE ACTIVATOR CLEAR — JOHNSON & JOHNSON SURGICAL VISION, INC.TearCare MGX System - TearCare MGX Technology Kit — Sight Sciences, Inc.TEARSCIENCE ACTIVATOR CLEAR — JOHNSON & JOHNSON SURGICAL VISION, INC.LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) — TEARSCIENCE, INC.LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) — TEARSCIENCE, INC.iLux — Alcon Laboratories, Inc.TearCare System - TearCare SmartHub Kit — Sight Sciences, Inc.iLux — Alcon Laboratories, Inc.iLux — Alcon Laboratories, Inc.iLux — Alcon Laboratories, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-23 | Sight Sciences, Inc. | Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance charact |
| 2017-01-30 | Tearscience, Inc | Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration. |
| 2016-09-13 | Tearscience, Inc | Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem |
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