Cleared Traditional

ALCON ULTRACHOPPER

K091777 · Alcon Research, Ltd. · Ophthalmic
Oct 2009
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K091777 is an FDA 510(k) clearance for the ALCON ULTRACHOPPER, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Research, Ltd. (Irvine, US). The FDA issued a Cleared decision on October 20, 2009, 125 days after receiving the submission on June 17, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K091777 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2009
Decision Date October 20, 2009
Days to Decision 125 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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