Cleared Traditional

K091404 - IVUE, MODEL 100
(FDA 510(k) Clearance)

K091404 · Optovue, Inc. · Ophthalmic

Apr 2010

Decision

345d

Days

Class 2

Risk

K091404 is an FDA 510(k) clearance for the IVUE, MODEL 100. 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 April 22, 2010, 345 days after receiving the submission on May 12, 2009.

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	K091404 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2009
Decision Date	April 22, 2010
Days to Decision	345 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.