Cleared Traditional

SOLO-CARE AQUA ANTIMICROBIAL LENS CASE

K041820 · Ciba Vision Corporation · Ophthalmic
Sep 2005
Decision
430d
Days
Class 2
Risk

About This 510(k) Submission

K041820 is an FDA 510(k) clearance for the SOLO-CARE AQUA ANTIMICROBIAL LENS CASE, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on September 9, 2005, 430 days after receiving the submission on July 6, 2004. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K041820 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2004
Decision Date September 09, 2005
Days to Decision 430 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LRX — Case, Contact Lens
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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