Cleared Traditional

CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

K023732 · Ciba Vision Corporation · Ophthalmic
Dec 2002
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K023732 is an FDA 510(k) clearance for the CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, 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 December 10, 2002, 34 days after receiving the submission on November 6, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K023732 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2002
Decision Date December 10, 2002
Days to Decision 34 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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