Cleared Traditional

BIOFINITY (COMFILCON A) SOFT CONTACT LENS

K052560 · CooperVision, Inc. · Ophthalmic
Dec 2005
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K052560 is an FDA 510(k) clearance for the BIOFINITY (COMFILCON A) SOFT 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 December 6, 2005, 81 days after receiving the submission on September 16, 2005. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K052560 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2005
Decision Date December 06, 2005
Days to Decision 81 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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