Product code ORZ
- Device name
- Eyelid Thermal Pulsation System
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.5200
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Therapeutic application of heat and massage to the eyelids.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252409 | TearCare MGX System | Sight Sciences, Inc. | 2026-04-27 |
| K242786 | TearCare MGX System | Sight Sciences, Inc. | 2025-04-15 |
| K240512 | Tixel i (TXLI0001) | Novoxel , Ltd. | 2024-11-04 |
| K231084 | TearCare MGX System | Sight Sciences, Inc. | 2023-12-27 |
| K213045 | TearCare System | Sight Sciences, Inc. | 2021-12-21 |
| K200400 | Systane iLux2 | Tear Film Innovations, Inc. | 2020-05-21 |
| K192623 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2019-10-22 |
| K172645 | iLux Instrument, iLux Disposable | Tear Film Innovations, Inc. | 2017-12-26 |
| K161357 | LipiFlow Thermal Pulsation System | Tearscience, Inc. | 2016-11-04 |
| K133127 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2013-12-23 |
| K112704 | LIPIFLOW THERMAL PULSATION SYSTEM | Tearscience, Inc. | 2011-12-19 |
| DEN100017 | LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) | Tearscience, Inc. | 2011-06-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290117524077 | Tixel i | NOVOXEL LTD | 2026-04-06 |
| 07290117524084 | Tixel i HP | NOVOXEL LTD | 2026-04-06 |
| 00380650005748 | iLux | Alcon Laboratories, Inc. | 2026-03-13 |
| 00380650005731 | iLux | Alcon Laboratories, Inc. | 2026-03-13 |
| 20380650005728 | iLux | Alcon Laboratories, Inc. | 2026-03-13 |
| 00858027006549 | TearCare MGX System - TearCare MGX Technology Kit | Sight Sciences, Inc. | 2025-04-30 |
| 00858027006297 | TearCare MGX System - TearCare MGX SmartLids | Sight Sciences, Inc. | 2025-04-29 |
| 00858027006495 | TearCare System - TearCare SmartLids | Sight Sciences, Inc. | 2022-03-03 |
| 00858027006457 | TearCare System - TearCare SmartHub Kit | Sight Sciences, Inc. | 2022-03-03 |
| 00810051250022 | TEARSCIENCE ACTIVATOR CLEAR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2021-10-18 |
| 10810051250074 | TEARSCIENCE ACTIVATOR CLEAR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2021-10-18 |
| 10810051250029 | TEARSCIENCE ACTIVATOR CLEAR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2021-10-18 |
| 00810051250077 | TEARSCIENCE ACTIVATOR CLEAR | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2021-10-18 |
| 00864461000401 | iLux | Alcon Laboratories, Inc. | 2018-11-05 |
| 00864461000418 | iLux | Alcon Laboratories, Inc. | 2018-11-05 |
| 00859623006315 | LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE | TEARSCIENCE, INC. | 2016-12-24 |
| 20859623006333 | LIPIFLOW SYSTEM ACTIVATOR II (DISPOSABLE | TEARSCIENCE, INC. | 2016-12-24 |
| 00859623006711 | LIPIFLOW SYSTEM ACTIVATOR II CABLE KIT | TEARSCIENCE, INC. | 2016-12-24 |
| 00859623006117 | LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) | TEARSCIENCE, INC. | 2016-09-23 |
| 20859623006135 | LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) | TEARSCIENCE, INC. | 2016-09-23 |
| 00859623006216 | LIPIFLOW SYSTEM ACTIVATOR (DISPOSABLE) | TEARSCIENCE, INC. | 2016-09-23 |
| 00859623006414 | LIPIFLOW SYSTEM CONSOLE | TEARSCIENCE, INC. | 2016-09-23 |