Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

97 results for "CooperVision, Inc."
1–24 of 97
Search insights Median review: 72d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 25, 2024
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable...
K234127 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Feb 04, 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira...
K220070 · LPL
CooperVision, Inc.
Ophthalmic · 25d
Cleared Oct 26, 2021
Avaira Vitality
K213164 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Oct 20, 2020
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1...
K202756 · LPL
CooperVision, Inc.
Ophthalmic · 29d
Cleared Mar 23, 2020
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon...
K191763 · LPL
CooperVision, Inc.
Ophthalmic · 266d
Cleared Apr 29, 2019
MyDay
K190965 · LPL
CooperVision, Inc.
Ophthalmic · 17d
Cleared Dec 11, 2018
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens...
K181920 · LPL
CooperVision, Inc.
Ophthalmic · 146d
Cleared CT Jul 13, 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · LPL
CooperVision, Inc.
Ophthalmic · 112d
Cleared Dec 23, 2013
AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
K133627 · LPL
CooperVision, Inc.
Ophthalmic · 27d
Cleared Aug 30, 2013
SUS (STENFILCON A) CONTACT LENS
K131378 · LPL
CooperVision, Inc.
Ophthalmic · 108d
Cleared May 30, 2013
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
K123202 · LPL
CooperVision, Inc.
Ophthalmic · 230d
Cleared Apr 03, 2012
AVAIRA (ENFILCON A) CONTACT LENS
K113759 · LPL
CooperVision, Inc.
Ophthalmic · 104d
Cleared Dec 21, 2011
PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC,...
K112302 · LPL
CooperVision, Inc.
Ophthalmic · 132d
Cleared Dec 02, 2011
BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
K113267 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Dec 02, 2011
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
K113245 · LPL
CooperVision, Inc.
Ophthalmic · 30d
Cleared Sep 15, 2011
PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
K111966 · LPL
CooperVision, Inc.
Ophthalmic · 66d
Cleared Jun 29, 2011
PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS
K110099 · LPL
CooperVision, Inc.
Ophthalmic · 167d
Cleared Jan 05, 2010
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS
K091339 · LPL
CooperVision, Inc.
Ophthalmic · 244d
Cleared Sep 29, 2008
PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR
K081865 · LPL
CooperVision, Inc.
Ophthalmic · 90d
Cleared Jan 04, 2008
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K071736 · LPL
CooperVision, Inc.
Ophthalmic · 192d
Cleared Nov 22, 2006
PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
K061948 · MVN
CooperVision, Inc.
Ophthalmic · 135d
Cleared Dec 06, 2005
BIOFINITY (COMFILCON A) SOFT CONTACT LENS
K052560 · LPL
CooperVision, Inc.
Ophthalmic · 81d
Cleared May 13, 2005
PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T...
K050717 · LPL
CooperVision, Inc.
Ophthalmic · 53d
Cleared Nov 16, 2004
FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
K042824 · LPL
CooperVision, Inc.
Ophthalmic · 35d