Cleared Traditional

K014202 - COMPLETE BRAND MULTI-PURPOSE SOLUTION (FDA 510(k) Clearance)

Feb 2002
Decision
61d
Days
Class 2
Risk

K014202 is an FDA 510(k) clearance for the COMPLETE BRAND MULTI-PURPOSE SOLUTION. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on February 20, 2002, 61 days after receiving the submission on December 21, 2001.

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

Submission Details

510(k) Number K014202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date February 20, 2002
Days to Decision 61 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