Cleared Traditional

PROCARE PLUS VITRECTOMY SYSTEM

K120170 · Visioncare Devices, Inc. · Ophthalmic
May 2012
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K120170 is an FDA 510(k) clearance for the PROCARE PLUS VITRECTOMY SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Visioncare Devices, Inc. (Redding, US). The FDA issued a Cleared decision on May 30, 2012, 132 days after receiving the submission on January 19, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K120170 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2012
Decision Date May 30, 2012
Days to Decision 132 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150

Similar Devices — HQE Instrument, Vitreous Aspiration And Cutting, Ac-powered

All 148
UniVit HE, UniVit UHS
K212763 · Visioncare Devices, LLC · Aug 2022
Cetus system, Cetus probe
K170183 · A.R.C Laser GmbH · Sep 2017
Bi-Blade Vitrectomy Cutter
K153168 · Medical Instrument Development Laboratories · Apr 2016
CONSTELLATION VISION SYSTEM
K141065 · Alcon Research, Ltd. · Aug 2014
VERSAVIT
K121675 · Synergetics, Inc. · Jun 2012
ULTIMATE VIT ENHAMCER (UVE)
K102222 · Medical Instrument Development Laboratories, Inc. · Apr 2011