Cleared Traditional

ALCON MULTI-PURPOSE DISINFECTING SOLUTION

K050729 · Alcon Research, Ltd. · Ophthalmic
Sep 2005
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K050729 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE DISINFECTING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Research, Ltd. (Fort Worth, US). The FDA issued a Cleared decision on September 14, 2005, 177 days after receiving the submission on March 21, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K050729 FDA.gov
FDA Decision Cleared SESE
Date Received March 21, 2005
Decision Date September 14, 2005
Days to Decision 177 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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