Cleared Traditional

AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K071736 · CooperVision, Inc. · Ophthalmic
Jan 2008
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K071736 is an FDA 510(k) clearance for the AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on January 4, 2008, 192 days after receiving the submission on June 26, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K071736 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2007
Decision Date January 04, 2008
Days to Decision 192 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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