Cleared Traditional

IVUE 500

K133892 · Optovue, Inc. · Ophthalmic
Mar 2014
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K133892 is an FDA 510(k) clearance for the IVUE 500, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on March 19, 2014, 89 days after receiving the submission on December 20, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K133892 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2013
Decision Date March 19, 2014
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

Similar Devices — HLI Ophthalmoscope, Ac-powered

All 86
RTVue XR OCT Avanti with AngioVue Software
K153080 · Optovue, Inc. · Feb 2016
EnFocus 2300, EnFocus 4400
K150722 · Bioptigen, Inc. · Dec 2015
OCT-Camera
K142953 · Optomedical Technologies GmbH · Mar 2015
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · Propper Manufacturing Co., Inc. · Sep 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · Centervue S.P.A. · Apr 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · Amico Diagnostic Incorporated · Mar 2014