Cleared Traditional

CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS

K062262 · Ciba Vision Corporation · Ophthalmic
Nov 2006
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K062262 is an FDA 510(k) clearance for the CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS, 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 November 14, 2006, 102 days after receiving the submission on August 4, 2006. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K062262 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2006
Decision Date November 14, 2006
Days to Decision 102 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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