LipiFlow Thermal Pulsation System
FDA 510(k) clearance K192623 · decided 2019-10-22
Clearance details
- K-number
- K192623
- Device name
- LipiFlow Thermal Pulsation System
- Applicant
- Tearscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-23
- Decision date
- 2019-10-22
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- ORZ
- Device class
- 2
- Regulation number
- 886.5200
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TearCare MGX System (K252409) | Sight Sciences, Inc. | 2026-04-27 |
| TearCare MGX System (K242786) | Sight Sciences, Inc. | 2025-04-15 |
| Tixel i (TXLI0001) (K240512) | Novoxel , Ltd. | 2024-11-04 |
| TearCare MGX System (K231084) | Sight Sciences, Inc. | 2023-12-27 |
| TearCare System (K213045) | Sight Sciences, Inc. | 2021-12-21 |
| Systane iLux2 (K200400) | Tear Film Innovations, Inc. | 2020-05-21 |
| iLux Instrument, iLux Disposable (K172645) | Tear Film Innovations, Inc. | 2017-12-26 |
| LipiFlow Thermal Pulsation System (K161357) | Tearscience, Inc. | 2016-11-04 |
| LIPIFLOW THERMAL PULSATION SYSTEM (K133127) | Tearscience, Inc. | 2013-12-23 |
| LIPIFLOW THERMAL PULSATION SYSTEM (K112704) | Tearscience, Inc. | 2011-12-19 |
| LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM) (DEN100017) | Tearscience, Inc. | 2011-06-28 |
Recalls involving this device
No recalls on record reference this clearance.