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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100443 | DEFINITIVE, FLEXLENS - SILICONE HYDROGEL | X-Cel Contacts, Inc. | 2010-10-28 | Traditional | PDF ↗ |
| K100456 | CVUE ADVANCED DEFINITIVE | Unilens Corp., USA | 2010-10-28 | Traditional | PDF ↗ |
| K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010-09-14 | Traditional | PDF ↗ |
| K101122 | BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS | Benz Research and Development Corp. | 2010-08-09 | Traditional | PDF ↗ |
| K091327 | ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES | Alden Optical Labs., Inc. | 2010-06-25 | Special | PDF ↗ |
| K100349 | VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER | Johnson & Johnson Vision Care, Inc. | 2010-05-21 | Traditional | PDF ↗ |
| K092852 | SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | St. shine Optical Co., Ltd. | 2010-03-11 | Traditional | PDF ↗ |
| K091339 | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | 2010-01-05 | Traditional | PDF ↗ |
| K090806 | SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON | Safilens, S.R.L. | 2009-12-18 | Traditional | PDF ↗ |
| K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | Innova Vision, Inc. | 2009-09-03 | Traditional | PDF ↗ |
| K082879 | EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | I-See Vision Technology, Inc. | 2009-06-16 | Traditional | PDF ↗ |
| K082880 | EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS | I-See Vision Technology, Inc. | 2009-06-16 | Traditional | PDF ↗ |
| K082883 | EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR | I-See Vision Technology, Inc. | 2009-06-16 | Traditional | PDF ↗ |
| K083216 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | 2009-04-14 | Special | PDF ↗ |
| K080794 | POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Polyvue Distribution, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K081865 | PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR | CooperVision, Inc. | 2008-09-29 | Special | PDF ↗ |
| K082393 | CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Unilens Corp., USA | 2008-09-11 | Special | PDF ↗ |
| K080512 | REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Metro Optics of Austin, Inc. | 2008-07-23 | Traditional | PDF ↗ |
| K073621 | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT | Art Optical Contact Lens, Inc. | 2008-07-03 | Traditional | PDF ↗ |
| K080686 | WESTCON HORIZON 49% (HIOXIFILCON B) | Westcon Contact Lens Co. | 2008-04-22 | Traditional | PDF ↗ |
| K073485 | VISTAKON (NARAFILCON) A SOFT CONTACT LENS | Johnson & Johnson Vision Care, Inc. | 2008-03-03 | Traditional | PDF ↗ |
| K073459 | CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES | Ciba Vision Corporation | 2008-02-28 | Traditional | PDF ↗ |
| K072777 | CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES | Ciba Vision Corporation | 2008-01-24 | Traditional | PDF ↗ |
| K071736 | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | 2008-01-04 | Traditional | PDF ↗ |
| K062854 | BENZ-G 4X HIOXIFILCON D | Benz Research and Development Corp. | 2007-08-06 | Traditional | PDF ↗ |
| K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | Innova Vision, Inc. | 2007-06-07 | Traditional | PDF ↗ |
| K070308 | FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR | X-Cel Contacts | 2007-03-12 | Traditional | PDF ↗ |
| K062262 | CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIGNS | Ciba Vision Corporation | 2006-11-14 | Traditional | PDF ↗ |
| K062614 | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) | Johnson & Johnson Vision Care, Inc. | 2006-11-01 | Special | PDF ↗ |
| K060821 | SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES | Specialeyes, LLC | 2006-05-18 | Traditional | PDF ↗ |
| K052290 | AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS | Clearlab Pte , Ltd. | 2006-05-15 | Traditional | PDF ↗ |
| K051477 | MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) | Mi Gwang Contact Lens Co., Ltd. | 2006-03-10 | Traditional | PDF ↗ |
| K052606 | MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS | Marietta Vision | 2005-12-15 | Special | PDF ↗ |
| K052560 | BIOFINITY (COMFILCON A) SOFT CONTACT LENS | CooperVision, Inc. | 2005-12-06 | Traditional | PDF ↗ |
| K052703 | ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL | Alden Optical Labs., Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K051095 | 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Optical Connection, Inc. | 2005-08-16 | Traditional | PDF ↗ |
| K051129 | DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Innova Vision, Inc. | 2005-08-12 | Traditional | PDF ↗ |
| K051430 | EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) | Hydrogel Vision Corporation | 2005-07-18 | Traditional | PDF ↗ |
| K051184 | 55 SV, MULTIFOCAL AND TORIC (OCUFILCON C) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | United Contact Lens, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K050948 | PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2005-05-18 | Abbreviated | PDF ↗ |
| K050717 | PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL TORIC | CooperVision, Inc. | 2005-05-13 | Traditional | PDF ↗ |
| K050157 | MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS | Bausch & Lomb, Inc. | 2005-04-26 | Traditional | PDF ↗ |
| K050743 | AQUAFLEX 2 (TEFILCON) CONTACT LENS | Unilens Corp., USA | 2005-04-13 | Special | PDF ↗ |
| K040303 | 59% EXTREME H2O (HIOXIFILCON A) SOFT CONTACT LENS | Hydrogel Vision Corporation | 2005-02-02 | Traditional | PDF ↗ |
| K043540 | HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES | Westcon Contact Lens Co., Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K043129 | PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) | Opti-Centre Laboratories | 2005-01-12 | Traditional | PDF ↗ |
| K042824 | FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS | CooperVision, Inc. | 2004-11-16 | Traditional | PDF ↗ |
| K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | Vistakon | 2004-10-28 | Traditional | PDF ↗ |
| K042435 | COOPER PROSTHETIC | CooperVision, Inc. | 2004-10-26 | Traditional | PDF ↗ |
| K042242 | ALDEN HP (HIOXIFILCON B) SPHERE & TORIC SOFT CONTACT LENSES | Alden Optical Labs., Inc. | 2004-09-15 | Special | PDF ↗ |
| K033655 | SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | 2004-07-30 | Traditional | PDF ↗ |
| K041700 | CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR | Cantor & Nissel , Ltd. | 2004-07-30 | Traditional | PDF ↗ |
| K041138 | LEO COLORS, LEO ASPHERIC COLORS, LEO TORIC COLORS | CooperVision, Inc. | 2004-07-23 | Traditional | PDF ↗ |
| K041608 | C-VUE 55 TORIC (METHAFILCON A) MULTIFOCAL CONTACT LENS | Unilens Corp., USA | 2004-07-07 | Special | PDF ↗ |
| K040900 | S-42 UV, T-42 UV TORIC AND M-42 UV MULTIFOCAL (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Optical Connection, Inc. | 2004-06-15 | Traditional | PDF ↗ |
| K033919 | CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS | Ciba Vision Corporation | 2004-03-12 | Traditional | PDF ↗ |
| K033136 | I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 | Innova Vision, Inc. | 2004-03-05 | Traditional | PDF ↗ |
| K031774 | HORIZON (METHAFILCON A) DAILY WEAR SPHERE AND TORIC CONTACT LENSES | Westcon Contact Lens Co., Inc. | 2004-02-20 | Traditional | PDF ↗ |
| K033969 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Vistakon | 2004-02-04 | Traditional | PDF ↗ |
| K032873 | PROCLEAR COMPATIBLES MULTIFOCAL | CooperVision, Inc. | 2003-11-07 | Traditional | PDF ↗ |
| K032340 | VISTAKON (GALYFILCON A) SOFT CONTACT LENS | Johnson & Johnson Vision Care, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032256 | QUASAR-QUASAR PLUS-QUASAR TORIC (HYBUFOCON A, HEXAFOCON A, PAFLUFOCON B) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT LE | No 7 Contact Lens Laboratory , Ltd. | 2003-08-29 | Traditional | PDF ↗ |
| K031532 | SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR | Metro Optics of Austin, Inc. | 2003-08-01 | Traditional | PDF ↗ |
| K031477 | HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS | Ocular Sciences, Inc. | 2003-07-18 | Abbreviated | PDF ↗ |
| K030842 | ENI-EYE Q TORIC (ACOFILCON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR, ENI-EYE (ACOFILCON) SOFT (HYDROP | Soflex Contact Lens Industries , Ltd. | 2003-06-06 | Traditional | PDF ↗ |
| K030593 | FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC | X-Cel Contacts, A Walman Co. | 2003-05-30 | Traditional | PDF ↗ |
| K030748 | AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER | Clearlab Pte , Ltd. | 2003-05-14 | Traditional | PDF ↗ |
| K030548 | SAVIEW 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | St. shine Optical Co., Ltd. | 2003-04-04 | Traditional | PDF ↗ |
| K030167 | MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER | Clearlab Pte , Ltd. | 2003-04-02 | Traditional | PDF ↗ |
| K030027 | GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49% | Gelflex Laboratories | 2003-04-01 | Traditional | PDF ↗ |
| K023987 | CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Contamac, Ltd. | 2003-02-26 | Traditional | PDF ↗ |
| K023989 | CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Contamac, Ltd. | 2003-02-26 | Traditional | PDF ↗ |
| K024045 | CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Contamac, Ltd. | 2003-02-14 | Traditional | PDF ↗ |
| K024003 | GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT | Gelflex | 2003-02-05 | Traditional | PDF ↗ |
| K024177 | ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Johnson & Johnson Vision Care, Inc. | 2003-01-22 | Traditional | PDF ↗ |
| K023791 | NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR | Softfocal Company, Inc. | 2003-01-10 | Traditional | PDF ↗ |
| K023349 | CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) | Contamac, Ltd. | 2002-12-24 | Traditional | PDF ↗ |
| K023077 | OCU-FLEX PEDIATRIC APHAKIC (OCUFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (LATHE-CUT) | Ocu-Ease Optical Products, Inc. | 2002-12-10 | Traditional | PDF ↗ |
| K023732 | CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Ciba Vision Corporation | 2002-12-10 | Traditional | PDF ↗ |
| K023530 | HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) | Westcon Contact Lens Co., Inc. | 2002-11-26 | Traditional | PDF ↗ |
| K021907 | IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Igel Vision Care Pte , Ltd. | 2002-09-04 | Traditional | PDF ↗ |
| K021720 | MULTIVISION METHAFILCON A SOFT (HYDROPILIC) MULTIFOCAL LENS FOR DAILY WEAR | Soflex Isralens Contact Lens , Ltd. | 2002-08-12 | Traditional | PDF ↗ |
| K020855 | IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFT | Igel Vision Care Pte , Ltd. | 2002-06-04 | Traditional | PDF ↗ |
| K021295 | SAVIEW TORIC 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | St. shine Optical Co., Ltd. | 2002-06-04 | Traditional | PDF ↗ |
| K020642 | SOFT K. AND SOFT K. TORIC (XYLOFICON A) SOFT (HYDROPHILLIC) KERATOCONUS CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | 2002-05-24 | Traditional | PDF ↗ |
| K020927 | BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb | 2002-05-16 | Traditional | PDF ↗ |
| K020608 | HD/HDT, (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) | Poly Vue Technolgies, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K020917 | SAVIEW 55F (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR | St. shine Optical Co., Ltd. | 2002-05-06 | Traditional | PDF ↗ |
| K020690 | OCU-FLEX-53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS | Ocu-Ease Optical Products, Inc. | 2002-04-26 | Traditional | PDF ↗ |
| K020392 | FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR | CooperVision, Inc. | 2002-04-26 | Traditional | PDF ↗ |
| K020139 | FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN | Ciba Vision Corporation | 2002-04-09 | Traditional | PDF ↗ |
| K020193 | OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Cl Mcintosh | 2002-02-28 | Abbreviated | PDF ↗ |
| K013973 | ACUVUE BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES; CLEAR AND TINTED (VISIBILITY AND/OR COSMETIC) WITH UV BLOC | Vistakon | 2002-02-26 | Traditional | PDF ↗ |
| K013445 | OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES | Florida Optical Engineering, Inc. | 2001-12-26 | Traditional | PDF ↗ |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | Sauflon Pharmaceuticals, Ltd. | 2001-12-26 | Traditional | PDF ↗ |
| K013377 | BIOMEDICS UV COLORS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS | Ocular Sciences Puerto Rico, Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K011893 | COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES | Contact Color Srl | 2001-12-06 | Traditional | PDF ↗ |
| K013220 | HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) | Poly Vue Technolgies, Inc. | 2001-11-20 | Traditional | PDF ↗ |
| K013469 | EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | 2001-11-20 | Traditional | PDF ↗ |
| K013467 | TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR | Soflex Contact Lens Industries , Ltd. | 2001-11-20 | Traditional | PDF ↗ |
Product code LPL · Class II · Ophthalmic. Data: openFDA.