Cleared Traditional

INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE

K112425 · Alcon Manufacturing, Ltd. · Ophthalmic
Nov 2011
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K112425 is an FDA 510(k) clearance for the INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Manufacturing, Ltd. (Irvine, US). The FDA issued a Cleared decision on November 21, 2011, 90 days after receiving the submission on August 23, 2011. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K112425 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2011
Decision Date November 21, 2011
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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