Cleared Traditional

IVUE WITH NORMATIVE DATABASE

K121739 · Optovue, Inc. · Ophthalmic
Jan 2013
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K121739 is an FDA 510(k) clearance for the IVUE WITH NORMATIVE DATABASE, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on January 18, 2013, 219 days after receiving the submission on June 13, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K121739 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2012
Decision Date January 18, 2013
Days to Decision 219 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

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