Cleared Traditional

LIPIVIEW OCULAR SURFACE INTERFEROMETER

K122481 · Tearscience, Inc. · Ophthalmic
Dec 2012
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K122481 is an FDA 510(k) clearance for the LIPIVIEW OCULAR SURFACE INTERFEROMETER, 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 31, 2012, 139 days after receiving the submission on August 14, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K122481 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2012
Decision Date December 31, 2012
Days to Decision 139 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