Cleared Traditional

RTVUE CAM WITH CORNEAL POWER UPGRADE

K111505 · Optovue, Inc. · Ophthalmic

Sep 2011

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K111505 is an FDA 510(k) clearance for the RTVUE CAM WITH CORNEAL POWER UPGRADE, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on September 8, 2011, 100 days after receiving the submission on May 31, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K111505 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2011
Decision Date	September 08, 2011
Days to Decision	100 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.