Cleared Traditional

CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

K024045 · Contamac, Ltd. · Ophthalmic
Feb 2003
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K024045 is an FDA 510(k) clearance for the CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT), a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Contamac, Ltd. (Grand Junction, US). The FDA issued a Cleared decision on February 14, 2003, 70 days after receiving the submission on December 6, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K024045 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2002
Decision Date February 14, 2003
Days to Decision 70 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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