FDA Product Code
FDA Product Code LPL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.5925
510(k) Clearances — 487 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180004 | Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens | Menicon Co, Ltd. | 2018-02-22 | Traditional | PDF ↗ |
| K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens | Tangible Science, LLC | 2017-12-13 | Traditional | PDF ↗ |
| K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | Visco Vision, Inc. | 2017-12-05 | Traditional | PDF ↗ |
| K173086 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2017-11-07 | Traditional | PDF ↗ |
| K172600 | AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal | Alcon Laboratories, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K171125 | Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | Tangible Science, LLC | 2017-10-18 | Traditional | PDF ↗ |
| K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA | Largan Medical Co., Ltd. | 2017-09-18 | Traditional | PDF ↗ |
| K172066 | DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. | 2017-08-09 | Special | PDF ↗ |
| K171157 | PolyDev Soft Contact Lenses | Polydev , Ltd. | 2017-06-02 | Traditional | PDF ↗ |
| K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017-01-04 | Traditional | PDF ↗ |
| K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | 2016-12-19 | Traditional | PDF ↗ |
| K161391 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016-11-30 | Traditional | PDF ↗ |
| K160245 | Visco (olifilcon A) soft contact lens | Visco Vision, Inc. | 2016-10-24 | Traditional | PDF ↗ |
| K162317 | Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens | St. shine Optical Co., Ltd. | 2016-10-21 | Traditional | PDF ↗ |
| K162596 | AIR OPTIX COLORS | Alcon Laboratories, Inc. | 2016-10-13 | Special | PDF ↗ |
| K161931 | Toricolors (hioxifilcon D) Soft Contact Lenses | Polydev , Ltd. | 2016-10-12 | Traditional | PDF ↗ |
| K161124 | EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear | Vision Science Co., Ltd. | 2016-08-26 | Traditional | PDF ↗ |
| K161098 | ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) | Joowon Innovation Co., Ltd. | 2016-08-22 | Traditional | PDF ↗ |
| K160472 | Hidrocor, Hidrocharme, and Natural Colors | Solotica | 2016-08-10 | Traditional | PDF ↗ |
| K160977 | PolyDev Soft Contact Lenses | Polydev , Ltd. | 2016-07-13 | Traditional | PDF ↗ |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | CooperVision, Inc. | 2016-07-13 | Traditional | PDF ↗ |
| K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016 | Visco Vision, Inc. | 2016-05-26 | Traditional | PDF ↗ |
| K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | Smart Performer Corp. , Ltd. | 2016-05-17 | Traditional | PDF ↗ |
| K160609 | AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric | Alcon Laboratories, Inc. | 2016-05-02 | Traditional | PDF ↗ |
| K153305 | EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear | Eyeyon Medical | 2016-04-08 | Traditional | PDF ↗ |
| K153766 | Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear | INTEROJO, Inc. | 2016-04-08 | Traditional | PDF ↗ |
| K160212 | ACUVUE (senofilcon C) Soft Contact Lens | Johnson & Johnson Vision Care, Inc. | 2016-03-28 | Traditional | PDF ↗ |
| K151847 | SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens | Smart Performer Corp. , Ltd. | 2016-03-04 | Traditional | PDF ↗ |
| K151918 | Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist | Bausch & Lomb, Incorporated | 2016-02-11 | Traditional | PDF ↗ |
| K153643 | Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives | Alcon Laboratories, Inc. | 2016-01-20 | Special | PDF ↗ |
| K153642 | DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal | Alcon Laboratories, Inc. | 2016-01-20 | Special | PDF ↗ |
| K152046 | Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) | Art Optical Contact Lens, Inc. | 2015-11-24 | Traditional | PDF ↗ |
| K151586 | Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2015-08-10 | Traditional | PDF ↗ |
| K150590 | CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, | Contamac, Ltd. | 2015-07-10 | Traditional | PDF ↗ |
| K141348 | VISCO SOFT CONTACT LENS | Visco Vision, Inc. | 2015-06-22 | Traditional | PDF ↗ |
| K150385 | NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | Visioneering Technologies, Inc. | 2015-04-30 | Traditional | PDF ↗ |
| K142820 | BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A) Soft (hydrophilie) Contact Lens for Daily Wear, BIOLENS Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear, BIOLENS Toric Multifocal (mangofilcon A) Soft (hydrophilic) contact lens for daily wear | Abb Optical Group, LLC | 2015-04-30 | Traditional | PDF ↗ |
| K143280 | BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens | Brien Holden Vision Pty , Ltd. | 2015-04-23 | Abbreviated | PDF ↗ |
| K150293 | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) | I-See Vision Technology, Inc. | 2015-04-15 | Traditional | PDF ↗ |
| K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | INTEROJO, Inc. | 2015-03-12 | Traditional | PDF ↗ |
| K143431 | Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | I-Codi Co., Ltd. | 2015-02-20 | Traditional | PDF ↗ |
| K143632 | Bausch + Lomb Biotrue ONEday for Astigmatism(nesofilcon A) Soft (hydrophilic) Contact Lens | Bausch & Lomb, Incorporated | 2015-02-13 | Traditional | PDF ↗ |
| K142641 | Intelliwave4 | Art Optical Contact Lens, Inc. | 2015-01-12 | Traditional | PDF ↗ |
| K143052 | Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2014-12-16 | Traditional | PDF ↗ |
| K142384 | DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) | Qualimed Srl | 2014-12-12 | Traditional | PDF ↗ |
| K142851 | CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens | Unilens Corp., USA | 2014-10-30 | Special | PDF ↗ |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | Unicon Optical Co., Ltd. | 2014-10-17 | Traditional | PDF ↗ |
| K140025 | AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | Pegavision Corporation | 2014-10-15 | Traditional | PDF ↗ |
| K142275 | Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens | Neo Vision Co., Ltd. | 2014-10-07 | Traditional | PDF ↗ |
| K141699 | VASSEN COLOR | Vassen Co., Ltd. | 2014-10-07 | Traditional | PDF ↗ |
| K141670 | ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA | Johnson & Johnson Vision Care, Inc. | 2014-09-18 | Traditional | PDF ↗ |
| K141280 | ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS | Seinoh Optical Co. , Ltd. | 2014-07-18 | Abbreviated | PDF ↗ |
| K133403 | FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS | Firestone Optics, Inc. | 2014-06-11 | Traditional | PDF ↗ |
| K133735 | EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Yung Sheng Optical Co., Ltd. | 2014-03-21 | Traditional | PDF ↗ |
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT | Sauflon Pharmaceuticals, Ltd. | 2014-03-05 | Traditional | PDF ↗ |
| K132714 | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) | Vision Science Co., Ltd. | 2014-03-05 | Traditional | PDF ↗ |
| K133472 | SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) | Souflon Pharmaceuticals, Ltd. | 2014-03-04 | Traditional | PDF ↗ |
| K133176 | AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL | Ciba Vision Corporation | 2014-01-29 | Traditional | PDF ↗ |
| K132854 | EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Yung Sheng Optical Co., Ltd. | 2013-12-23 | Traditional | PDF ↗ |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | CooperVision, Inc. | 2013-12-23 | Special | PDF ↗ |
| K132715 | BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS | Bausch & Lomb, Incorporated | 2013-12-20 | Traditional | PDF ↗ |
| K133079 | IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC) | Alden Optical Labs., Inc. | 2013-12-17 | Traditional | PDF ↗ |
| K131208 | BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, | Bausch & Lomb, Inc. | 2013-09-11 | Traditional | PDF ↗ |
| K130931 | EASY DAY (METHAFILCON A) 1-DAY SOFT (HYDROPHILIC) CONTACT LENS | Jiangsu Horien Contact Lens Co., Ltd. | 2013-08-30 | Traditional | PDF ↗ |
| K131378 | SUS (STENFILCON A) CONTACT LENS | CooperVision, Inc. | 2013-08-30 | Traditional | PDF ↗ |
| K132146 | SAVIEW-AQUA 58 UV (ETAFILCON A) VISIBILITY TINTED SOFT (HYDROPHILIC) CONTACT LENS, SAVIEW-AQUA 58 UV TORIC (ETAFILCON A) | St. shine Optical Co., Ltd. | 2013-08-30 | Traditional | PDF ↗ |
| K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Sauflon Pharmaceuticals, Ltd. | 2013-08-05 | Traditional | PDF ↗ |
| K123431 | DREAM COLOR I (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, DREAM COLOR II (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, D | Dreamcon Co., Ltd. | 2013-06-17 | Traditional | PDF ↗ |
| K123202 | PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | 2013-05-30 | Special | PDF ↗ |
| K120756 | LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE | The Lagado Corp. | 2013-05-13 | Traditional | PDF ↗ |
| K123973 | AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | Pegavision Corporation | 2013-04-23 | Traditional | PDF ↗ |
| K123484 | SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS | St. shine Optical Co., Ltd. | 2013-03-29 | Traditional | PDF ↗ |
| K122220 | ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S | Soflex Limited | 2013-03-19 | Traditional | PDF ↗ |
| K123994 | DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL | Ciba Vision Corporation | 2013-02-21 | Traditional | PDF ↗ |
| K122315 | FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC | Oculus Private Limited | 2013-02-15 | Traditional | PDF ↗ |
| K122575 | BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI | Bausch & Lomb, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K122213 | ENI-EYE SH SPHERE (EFROFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Soflex Limited | 2012-12-12 | Traditional | PDF ↗ |
| K121201 | SAVIE-AQUA 55UV (METHAFILCON A) TINNTED BLUE SOFT (HYDROPHILIC) CONTACT LENS | St. shine Optical Co., Ltd. | 2012-10-26 | Traditional | PDF ↗ |
| K121652 | CVUE ADVANCED HYDRA VUE | Unilens Corp., USA | 2012-10-05 | Traditional | PDF ↗ |
| K121519 | ISIGHT | C&E GP Specialists, Inc. | 2012-09-18 | Traditional | PDF ↗ |
| K121324 | AVT NATURASOFT | Advanced Vision Technologies | 2012-08-23 | Traditional | PDF ↗ |
| K112373 | CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION | Innova Vision, Inc. | 2012-08-17 | Traditional | PDF ↗ |
| K113703 | BAUSCH + LOMB NESOFILCON A CONTACT LENS | Bausch & Lomb, Incorporated | 2012-06-05 | Traditional | PDF ↗ |
| K110835 | GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | GEO MEDICAL CO., LTD. | 2012-04-26 | Traditional | PDF ↗ |
| K120028 | AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES | Pegavision Corporation | 2012-04-17 | Traditional | PDF ↗ |
| K113759 | AVAIRA (ENFILCON A) CONTACT LENS | CooperVision, Inc. | 2012-04-03 | Special | PDF ↗ |
| K113168 | DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC | Ciba Vision Corporation | 2012-03-30 | Traditional | PDF ↗ |
| K112302 | PROCLEAR TORIC XR, PROCLEAR MULTIFOCAL XR, PROCLEAR MULTIFOCAL TORIC, PROCLEAR SPHERE & ASPHERE, TORIC CONTACT LENSES | CooperVision, Inc. | 2011-12-21 | Traditional | PDF ↗ |
| K113245 | AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL | CooperVision, Inc. | 2011-12-02 | Special | PDF ↗ |
| K113267 | BIOPMEDICS52,52 1DAY,52 TORIC,52 1DAY TORIC | CooperVision, Inc. | 2011-12-02 | Special | PDF ↗ |
| K111267 | CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) | Abbconcise Optical Group, LLC | 2011-11-08 | Traditional | PDF ↗ |
| K111345 | SEE CLEAR SOFT CONTACT LENS, SEE CLEAR COLOR SOFT CONTACT LENS, FIERCE SOFT CONTACT LENS | The See Clear Company, Inc. | 2011-11-02 | Traditional | PDF ↗ |
| K111966 | PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC | CooperVision, Inc. | 2011-09-15 | Special | PDF ↗ |
| K103132 | FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI | Oculus Private Limited | 2011-09-08 | Traditional | PDF ↗ |
| K110261 | ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS | Soflex Limited | 2011-07-28 | Traditional | PDF ↗ |
| K110099 | PROCLEAR TORIC XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULTIFOCAL XR SOFT (HYDROPHILIC) CONTACT LENS; PROCLEAR MULT | CooperVision, Inc. | 2011-06-29 | Traditional | PDF ↗ |
| K102895 | ONE DAY FLAT PACK | Menicon Co, Ltd. | 2011-04-28 | Traditional | PDF ↗ |
| K102557 | NOVAKONE SPHERICAL AND TORIC LENSES | Alden Optical Labs., Inc. | 2011-04-26 | Traditional | PDF ↗ |
| K110452 | SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2, | Unilens Corp., USA | 2011-04-20 | Special | PDF ↗ |
| K100456 | CVUE ADVANCED DEFINITIVE | Unilens Corp., USA | 2010-10-28 | Traditional | PDF ↗ |
Product code LPL · Class II · Ophthalmic. Data: openFDA.