Cleared Traditional

INFINITI(R) VISION SYSTEM

K120912 · Alcon Manufacturing, Ltd. · Ophthalmic
Jun 2012
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K120912 is an FDA 510(k) clearance for the INFINITI(R) VISION SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Manufacturing, Ltd. (Irvine, US). The FDA issued a Cleared decision on June 15, 2012, 81 days after receiving the submission on March 26, 2012. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K120912 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2012
Decision Date June 15, 2012
Days to Decision 81 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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