Cleared Traditional

K163475 - iVue
(FDA 510(k) Clearance)

K163475 · Optovue, Inc. · Ophthalmic

Jun 2017

Decision

179d

Days

Class 2

Risk

K163475 is an FDA 510(k) clearance for the iVue. This device is classified as a Tomography, Optical Coherence (Class II — Special Controls, product code OBO).

Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on June 9, 2017, 179 days after receiving the submission on December 12, 2016.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..

Submission Details

510(k) Number	K163475 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2016
Decision Date	June 09, 2017
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.1570
Definition	Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.