510(k) K182506

LipiScan Dynamic Meibomian Imager by Tearscience, Inc. — Product Code HKI

K182506 is an FDA 510(k) premarket notification submitted by Tearscience, Inc. for the device "LipiScan Dynamic Meibomian Imager". The FDA issued a decision of Substantially Equivalent on December 10, 2018. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Tearscience, Inc. has at least 8 other 510(k) clearances on record.