Cleared Special

RTVUE XR OCT

K120238 · Optovue, Inc. · Ophthalmic
Apr 2012
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K120238 is an FDA 510(k) clearance for the RTVUE XR OCT, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on April 3, 2012, 68 days after receiving the submission on January 26, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K120238 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2012
Decision Date April 03, 2012
Days to Decision 68 days
Submission Type Special
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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