Cleared Traditional

K122572 - ICAM FUNDUS CAMERA
(FDA 510(k) Clearance)

K122572 · Optovue, Inc. · Ophthalmic
Jan 2013
Decision
141d
Days
Class 2
Risk

K122572 is an FDA 510(k) clearance for the ICAM FUNDUS CAMERA. This device is classified as a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI).

Submitted by Optovue, Inc. (Fremont, US). The FDA issued a Cleared decision on January 11, 2013, 141 days after receiving the submission on August 23, 2012.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K122572 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2012
Decision Date January 11, 2013
Days to Decision 141 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120