Systane iLux2
FDA 510(k) K200400 · Tear Film Innovations, Inc.
510(k) numberK200400
Submission
- Device name
- Systane iLux2
- Applicant
- Tear Film Innovations, Inc.
Carlsbad, CA, US - Received
- February 18, 2020
- Decision date
- May 21, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
Other 510(k)s with product code ORZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K192623 | LipiFlow Thermal Pulsation SystemORZ · Special | Tearscience, Inc. | 10/22/2019SE |
| K172645 | iLux Instrument, iLux DisposableORZ · Traditional | Tear Film Innovations, Inc. | 12/26/2017SE |
| K161357 | LipiFlow Thermal Pulsation SystemORZ · Special | Tearscience, Inc. | 11/04/2016SE |
| K133127 | Lipiflow Thermal Pulsation SystemORZ · Traditional | Tearscience, Inc. | 12/23/2013SE |
More from Tearscience, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172645 | iLux Instrument, iLux DisposableORZ · Traditional | 12/26/2017SE |
Questions and answers
When was Systane iLux2 cleared by the FDA?
Systane iLux2 (K200400) received a 510(k) decision of Substantially Equivalent on May 21, 2020, 93 days after the submission was received.
What is the product code of K200400?
The FDA product code is ORZ – Eyelid Thermal Pulsation System, a Class II (moderate risk) device regulated under 21 CFR 886.5200.