LipiScan Dynamic Meibomian Imager
K-Number: K182506 · 2018-12-10
ApplicantTearscience, Inc.
Decision Date2018-12-10
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
LipiScan Dynamic Meibomian Imager is a medical device manufactured by Tearscience, Inc.. It received FDA 510(k) clearance on 2018-12-10 under approval number K182506. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LipiScan Dynamic Meibomian Imager?
LipiScan Dynamic Meibomian Imager is a medical device that received FDA 510(k) clearance on 2018-12-10. It is manufactured by Tearscience, Inc.. The 510(k) number is K182506.
When was LipiScan Dynamic Meibomian Imager approved by the FDA?
LipiScan Dynamic Meibomian Imager received FDA 510(k) clearance on 2018-12-10, under approval number K182506.
What company makes LipiScan Dynamic Meibomian Imager?
LipiScan Dynamic Meibomian Imager is manufactured by Tearscience, Inc..
What is the FDA product code for LipiScan Dynamic Meibomian Imager?
The FDA product code for LipiScan Dynamic Meibomian Imager is HKI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.