Cleared Traditional

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

K072777 · Ciba Vision Corporation · Ophthalmic
Jan 2008
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K072777 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 January 24, 2008, 118 days after receiving the submission on September 28, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K072777 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2007
Decision Date January 24, 2008
Days to Decision 118 days
Submission Type Traditional
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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