Cleared Special

CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES

K083216 · Ciba Vision Corporation · Ophthalmic
Apr 2009
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K083216 is an FDA 510(k) clearance for the CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on April 14, 2009, 165 days after receiving the submission on October 31, 2008. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K083216 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 2008
Decision Date April 14, 2009
Days to Decision 165 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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