Lipiview Ocular Surface Interferometer
FDA 510(k) K091935 · Tearscience, Inc.
510(k) numberK091935
Submission
- Device name
- Lipiview Ocular Surface Interferometer
- Applicant
- Tearscience, Inc.
Morrisville, NC, US - Received
- June 30, 2009
- Decision date
- October 23, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HKI – Camera, Ophthalmic, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1120
- Specialty
- Ophthalmic
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More from Optina Diagnostics, Inc.
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|---|---|---|
| K192623 | LipiFlow Thermal Pulsation SystemORZ · Special | 10/22/2019SE |
| K182506 | LipiScan Dynamic Meibomian ImagerHKI · Traditional | 12/10/2018SE |
| K161357 | LipiFlow Thermal Pulsation SystemORZ · Special | 11/04/2016SE |
| 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 |
Questions and answers
When was Lipiview Ocular Surface Interferometer cleared by the FDA?
Lipiview Ocular Surface Interferometer (K091935) received a 510(k) decision of Substantially Equivalent on October 23, 2009, 115 days after the submission was received.
What is the product code of K091935?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.