MVN · Class II · 21 CFR 886.5925

FDA Product Code MVN: Lens, Contact, (disposable)

Leading manufacturers include Ciba Vision Corporation, Bausch & Lomb, Inc. and CooperVision, Inc..

26
Total
26
Cleared
84d
Avg days
1999
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 36d recently vs 86d historically

FDA 510(k) Cleared Lens, Contact, (disposable) Devices (Product Code MVN)

26 devices
1–24 of 26
Cleared Jul 07, 2026
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens
K261812
Hoya Lamphun , Ltd.
Ophthalmic · 36d
Cleared Sep 22, 2020
DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202448
Alcon Laboratories, Inc.
Ophthalmic · 27d
Cleared Aug 21, 2020
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal
K202036
Alcon Laboratories, Inc.
Ophthalmic · 29d
Cleared Jun 15, 2015
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear
K150630
Yung Sheng Optical Co., Ltd.
Ophthalmic · 96d
Cleared Jan 16, 2015
Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens
K143190
Yung Sheng Optical Co., Ltd.
Ophthalmic · 72d
Cleared Jul 26, 2013
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
K130331
Sauflon Pharmaceuticals, Ltd.
Ophthalmic · 165d
Cleared Oct 25, 2011
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K112192
Bausch & Lomb, Inc.
Ophthalmic · 88d
Cleared Jun 10, 2008
SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS
K080755
Bausch & Lomb, Inc.
Ophthalmic · 85d
Cleared Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948
CooperVision, Inc.
Ophthalmic · 135d
Cleared May 27, 2005
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES
K050065
Ciba Vision Corporation
Ophthalmic · 135d
Cleared Mar 28, 2005
FRESHLOOK ONE-DAY COLOR CONTACT LENS
K050213
Ciba Vision Corporation
Ophthalmic · 56d
Cleared Dec 15, 2003
FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES
K033701
Ciba Vision Corporation
Ophthalmic · 20d
Cleared Jul 25, 2001
BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
K011718
Bausch & Lomb, Inc.
Ophthalmic · 51d
Cleared Mar 23, 2001
FOCUS DAILIES (NELFILCON A) ONE-DAY SOFT CONTACT LENSES, FOCUS DAILIES PROGRESSIVES (NELFILCON A) ONE-DAY SOFT CONTACT
K010636
Ciba Vision Corporation
Ophthalmic · 18d
Cleared Mar 08, 2001
FOCUS DAILIES PROGRESSIVES
K003826
Ciba Vision Corporation
Ophthalmic · 87d
Cleared Nov 24, 1999
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
K993252
CooperVision, Inc.
Ophthalmic · 57d
Cleared Aug 18, 1999
DAILIES (NELFILCON A) ONE-DAY
K992446
Ciba Vision Johns Creek Mfg.
Ophthalmic · 27d
Cleared Jan 25, 1999
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS
K984273
Ciba Vision Corporation
Ophthalmic · 56d

About Product Code MVN - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code MVN since 1999, with 26 receiving FDA clearance (average review time: 84 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - MVN Product Code

Recent submissions under MVN have taken an average of 36 days to reach a decision - down from 86 days historically, suggesting improved FDA processing for this classification.

MVN devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →