510(k) K192623
- Device
- LipiFlow Thermal Pulsation System
- Applicant
- TearScience Inc.
- 510(k) number
- K192623
- Product code
- ORZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-22
- Date received
- 2019-09-23
- Regulation
- 886.5200
- Classification name
- Eyelid Thermal Pulsation System
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michelle Ricafort
- Address
- 1700 E. St. Andrew Pl. Santa Ana CA US 92705 92705
FDA Registration Numbers#
- 8043396
- 2031044
- 3010363671
- 3014193078
- 3012500984
- 1610287
- 1036836
- 3008169506
- 3007014520
- 3007113251
- 3010162782
- 2028159
- 3017056829
- 3010208880
- 3003144120
- 3009265194
- 2183744
- 3006262888
- 1056553
Source Documents#
Other 510(k) Records For Product Code ORZ #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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