Cleared Traditional

K102860 - ALCON MULTI-PIRPOSE DISINFECTING SOLUTION
(FDA 510(k) Clearance)

May 2011
Decision
222d
Days
Class 2
Risk

K102860 is an FDA 510(k) clearance for the ALCON MULTI-PIRPOSE DISINFECTING SOLUTION. This device is classified as 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 May 10, 2011, 222 days after receiving the submission on September 30, 2010.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K102860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2010
Decision Date May 10, 2011
Days to Decision 222 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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