Eyelid Thermal Pulsation System
FDA product code ORZ · 12 cleared devices
Class 2
Ophthalmic
- Regulation
- 21 CFR 886.5200
- Review panel
- OP
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2011-12-19 – 2026-08-18
Therapeutic application of heat and massage to the eyelids.
ORZ
2026-08-18
ORZ
2026-04-27
TearCare MGX System
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ORZ
2025-04-15
TearCare MGX System
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ORZ
2024-11-04
Tixel i (TXLI0001)
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ORZ
2023-12-27
TearCare MGX System
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ORZ
2021-12-21
TearCare System
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ORZ
2020-05-21
Systane iLux2
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ORZ
2019-10-22
LipiFlow Thermal Pulsation System
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ORZ
2017-12-26
iLux Instrument, iLux Disposable
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ORZ
2016-11-04
LipiFlow Thermal Pulsation System
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ORZ
2013-12-23
LIPIFLOW THERMAL PULSATION SYSTEM
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ORZ
2011-12-19
LIPIFLOW THERMAL PULSATION SYSTEM
View details →No matching devices.
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