Cleared Traditional

CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)

K023349 · Contamac, Ltd. · Ophthalmic
Dec 2002
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K023349 is an FDA 510(k) clearance for the CONTAFLEX GM3 58% (ACOFILCON A) 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 December 24, 2002, 78 days after receiving the submission on October 7, 2002. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K023349 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2002
Decision Date December 24, 2002
Days to Decision 78 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

Similar Devices — LPL Lenses, Soft Contact, Daily Wear

All 480
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1?; DAILIES TOTAL1? Multifocal
K254052 · Alcon Laboratories, Inc. · Feb 2026
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683 · Bruno Vision Care, LLC · Dec 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364 · St. shine Optical Co., Ltd. · Oct 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · Pegavision Corporation · Sep 2025