LipiFlow Thermal Pulsation System
FDA 510(k) K161357 · Tearscience, Inc.
510(k) numberK161357
Submission
- Device name
- LipiFlow Thermal Pulsation System
- Applicant
- Tearscience, Inc.
Morrisville, NC, US - Received
- May 16, 2016
- Decision date
- November 4, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ORZ – Eyelid Thermal Pulsation System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5200
- Specialty
- Ophthalmic
Therapeutic application of heat and massage to the eyelids.
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| K262479 | TearCare SystemORZ · Special | Sight Sciences, Inc. | 08/18/2026SE |
| K252409 | TearCare MGX SystemORZ · Traditional | Sight Sciences, Inc. | 04/27/2026SE |
| K242786 | TearCare MGX SystemORZ · Traditional | Sight Sciences, Inc. | 04/15/2025SE |
| K240512 | Tixel i (TXLI0001)ORZ · Traditional | Novoxel , Ltd. | 11/04/2024SE |
| K231084 | TearCare MGX SystemORZ · Traditional | Sight Sciences, Inc. | 12/27/2023SE |
| K213045 | TearCare SystemORZ · Traditional | Sight Sciences, Inc. | 12/21/2021SE |
| K200400 | Systane iLux2ORZ · Traditional | Tear Film Innovations, Inc. | 05/21/2020SE |
| K192623 | LipiFlow Thermal Pulsation SystemORZ · Special | Tearscience, Inc. | 10/22/2019SE |
| K172645 | iLux Instrument, iLux DisposableORZ · Traditional | Tear Film Innovations, Inc. | 12/26/2017SE |
| K133127 | Lipiflow Thermal Pulsation SystemORZ · Traditional | Tearscience, Inc. | 12/23/2013SE |
More from Tearscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K192623 | LipiFlow Thermal Pulsation SystemORZ · Special | 10/22/2019SE |
| K182506 | LipiScan Dynamic Meibomian ImagerHKI · Traditional | 12/10/2018SE |
| K152869 | LipiView II Ocular Surface InterferometerHKI · Traditional | 01/14/2016SE |
| K133127 | Lipiflow Thermal Pulsation SystemORZ · Traditional | 12/23/2013SE |
| K122481 | Lipiview Ocular Surface InterferometerHKI · Traditional | 12/31/2012SE |
| K112704 | Lipiflow Thermal Pulsation SystemORZ · Traditional | 12/19/2011SE |
| K091935 | Lipiview Ocular Surface InterferometerHKI · Traditional | 10/23/2009SE |
Questions and answers
When was LipiFlow Thermal Pulsation System cleared by the FDA?
LipiFlow Thermal Pulsation System (K161357) received a 510(k) decision of Substantially Equivalent on November 4, 2016, 172 days after the submission was received.
What is the product code of K161357?
The FDA product code is ORZ – Eyelid Thermal Pulsation System, a Class II (moderate risk) device regulated under 21 CFR 886.5200.