Cleared Traditional

CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES

K073459 · Ciba Vision Corporation · Ophthalmic
Feb 2008
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K073459 is an FDA 510(k) clearance for the CIBA VISION (LOTRAFILCON B) 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 February 28, 2008, 80 days after receiving the submission on December 10, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K073459 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2007
Decision Date February 28, 2008
Days to Decision 80 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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