Cleared Traditional

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE

K951728 · Mira, Inc. · Ophthalmic
Mar 1997
Decision
706d
Days
Class 2
Risk

About This 510(k) Submission

K951728 is an FDA 510(k) clearance for the SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on March 19, 1997, 706 days after receiving the submission on April 13, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K951728 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1995
Decision Date March 19, 1997
Days to Decision 706 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

Similar Devices — HLI Ophthalmoscope, Ac-powered

All 86
RTVue XR OCT Avanti with AngioVue Software
K153080 · Optovue, Inc. · Feb 2016
EnFocus 2300, EnFocus 4400
K150722 · Bioptigen, Inc. · Dec 2015
OCT-Camera
K142953 · Optomedical Technologies GmbH · Mar 2015
PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE
K141638 · Propper Manufacturing Co., Inc. · Sep 2014
CENTERVUE MACULAR INTEGRITY ASSESSMENT
K133758 · Centervue S.P.A. · Apr 2014
AMICO DH-W35 OPHTHALMOSCOPE SERIES
K131939 · Amico Diagnostic Incorporated · Mar 2014