Cleared Traditional

BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

K091339 · CooperVision, Inc. · Ophthalmic
Jan 2010
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K091339 is an FDA 510(k) clearance for the BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by CooperVision, Inc. (Norfolk, US). The FDA issued a Cleared decision on January 5, 2010, 244 days after receiving the submission on May 6, 2009. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K091339 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2009
Decision Date January 05, 2010
Days to Decision 244 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

More from CooperVision, Inc.

View all
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
K234127 · LPL · Jan 2024
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
K220070 · LPL · Feb 2022
Avaira Vitality
K213164 · LPL · Oct 2021
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
K202756 · LPL · Oct 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
K191763 · LPL · Mar 2020