LipiScan Dynamic Meibomian Imager
FDA 510(k) K182506 · Tearscience, Inc.
510(k) numberK182506
Submission
- Device name
- LipiScan Dynamic Meibomian Imager
- Applicant
- Tearscience, Inc.
Morrisville, NC, US - Received
- September 12, 2018
- Decision date
- December 10, 2018
- 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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Questions and answers
When was LipiScan Dynamic Meibomian Imager cleared by the FDA?
LipiScan Dynamic Meibomian Imager (K182506) received a 510(k) decision of Substantially Equivalent on December 10, 2018, 89 days after the submission was received.
What is the product code of K182506?
The FDA product code is HKI – Camera, Ophthalmic, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1120.