Cleared Traditional

AQUALASE CAPSULE WASH TIP

K093210 · Alcon Manufacturing, Ltd. · Ophthalmic
Mar 2010
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K093210 is an FDA 510(k) clearance for the AQUALASE CAPSULE WASH TIP, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Alcon Manufacturing, Ltd. (Irvine, US). The FDA issued a Cleared decision on March 4, 2010, 142 days after receiving the submission on October 13, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K093210 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2009
Decision Date March 04, 2010
Days to Decision 142 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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