ClearanceBrief
Panels › Ophthalmic › Product code LPL · Class 2

Lenses, Soft Contact, Daily Wear

Regulation 886.5925

11510(k)s in 12 months (489 all time)
1recalls in 12 months (71 all time)
50recalls that name a 510(k)
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Top companies in LPL

Company510(k)sRecalls
CooperVision, Inc.3719
Ciba Vision Corporation149
Alcon Laboratories, Inc.220
Bausch & Lomb211
Johnson & Johnson Vision Care, Inc.117
Pegavision Corporation140
Unilens Corp., USA140
Visco Vision, Inc.120
Alden Optical011
St. shine Optical Co., Ltd.110
Decided510(k)Device and applicantCode
Oct 7, 2014K142275Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
Neo Vision Co., Ltd., KR
LPL
Oct 7, 2014K141699VASSEN COLOR
Vassen Co., Ltd.
LPL
Sep 18, 2014K141670ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
Johnson & Johnson Vision Care, Inc.
LPL
Jul 18, 2014K141280ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
Seinoh Optical Co. , Ltd., TW
LPL
Jun 11, 2014K133403FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
Firestone Optics, Inc.
LPL
Mar 21, 2014K133735EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
Yung Sheng Optical Co., Ltd., TW
LPL
Mar 5, 2014K133740SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
Sauflon Pharmaceuticals, Ltd., GB
LPL
Mar 5, 2014K132714ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
Vision Science Co., Ltd.
LPL
Mar 4, 2014K133472SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
Souflon Pharmaceuticals, Ltd., GB
LPL
Jan 29, 2014K133176AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
Ciba Vision Corporation
LPL
Dec 23, 2013K133627AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
CooperVision, Inc.
LPL
Dec 23, 2013K132854EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Yung Sheng Optical Co., Ltd., TW
LPL
Dec 20, 2013K132715BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS
Bausch & Lomb, Incorporated
LPL
Dec 17, 2013K133079IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC)
Alden Optical Labs., Inc.
LPL
Sep 11, 2013K131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,
Bausch & Lomb, Inc.
LPL
Aug 30, 2013K132146SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A)
St. shine Optical Co., Ltd., TW
LPL
Aug 30, 2013K131378SUS (STENFILCON A) CONTACT LENS
CooperVision, Inc.
LPL
Aug 30, 2013K130931EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS
Jiangsu Horien Contact Lens Co., Ltd.
LPL
Aug 5, 2013K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
Sauflon Pharmaceuticals, Ltd., GB
LPL
Jun 17, 2013K123431DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D
Dreamcon Co., Ltd.
LPL
May 30, 2013K123202PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
CooperVision, Inc.
LPL
May 13, 2013K120756LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
The Lagado Corp.
LPL
Apr 23, 2013K123973AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
Pegavision Corporation, TW
LPL
Mar 29, 2013K123484SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
St. shine Optical Co., Ltd., TW
LPL
Mar 19, 2013K122220ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
Soflex Limited
LPL
Feb 21, 2013K123994DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
Ciba Vision Corporation
LPL
Feb 15, 2013K122315FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
Oculus Private Limited
LPL
Dec 20, 2012K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
Bausch & Lomb, Inc.
LPL
Dec 12, 2012K122213ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Soflex Limited
LPL
Oct 26, 2012K121201SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS
St. shine Optical Co., Ltd., TW
LPL
Oct 5, 2012K121652CVUE ADVANCED HYDRA VUE
Unilens Corp., USA
LPL
Sep 18, 2012K121519ISIGHT
C&E GP Specialists, Inc.
LPL
Aug 23, 2012K121324AVT NATURASOFT
Advanced Vision Technologies
LPL
Aug 17, 2012K112373CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION
Innova Vision, Inc.
LPL
Jun 5, 2012K113703BAUSCH + LOMB NESOFILCON A CONTACT LENS
Bausch & Lomb, Incorporated
LPL
Apr 26, 2012K110835GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
GEO MEDICAL CO., LTD.
LPL
Apr 17, 2012K120028AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES
Pegavision Corporation, TW
LPL
Apr 3, 2012K113759AVAIRA (ENFILCON A) CONTACT LENS
CooperVision, Inc.
LPL
Mar 30, 2012K113168DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
Ciba Vision Corporation
LPL
Dec 21, 2011K112302PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES
CooperVision, Inc.
LPL
Dec 2, 2011K113267BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC
CooperVision, Inc.
LPL
Dec 2, 2011K113245AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
CooperVision, Inc.
LPL
Nov 8, 2011K111267CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)
Abbconcise Optical Group, LLC
LPL
Nov 2, 2011K111345SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS
The See Clear Company, Inc.
LPL
Sep 15, 2011K111966PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC
CooperVision, Inc.
LPL
Sep 8, 2011K103132FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
Oculus Private Limited
LPL
Jul 28, 2011K110261ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
Soflex Limited
LPL
Jun 29, 2011K110099PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT
CooperVision, Inc.
LPL
Apr 28, 2011K102895ONE DAY FLAT PACK
Menicon Co, Ltd.
LPL
Apr 26, 2011K102557NOVAKONE SPHERICAL AND TORIC LENSES
Alden Optical Labs., Inc.
LPL

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