Cleared Traditional

LipiScan Dynamic Meibomian Imager

K182506 · Tearscience, Inc. · Ophthalmic
Dec 2018
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K182506 is an FDA 510(k) clearance for the LipiScan Dynamic Meibomian Imager, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Tearscience, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 10, 2018, 89 days after receiving the submission on September 12, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K182506 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2018
Decision Date December 10, 2018
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120