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 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 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 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 →