meddevicedb.com FDA Device Reference

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 4 of 5

K-Number Device Name Applicant Decision Date Clearance Type Summary
K012425 BIOMEDICS UV MULTIFOCAL Ocular Sciences Puerto Rico, Inc. 2001-10-12 Traditional PDF ↗
K011072 GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS Gelflex 2001-08-24 Traditional PDF ↗
K011256 TORIC LITE LENS Soflex Contact Lens Industries , Ltd. 2001-07-17 Traditional PDF ↗
K001962 S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- Bescon Co., Ltd. 2001-07-09 Traditional PDF ↗
K002099 S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- Bescon Co., Ltd. 2001-07-09 Traditional PDF ↗
K011542 SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) Specialty Ultravision, Inc. 2001-06-26 Traditional PDF ↗
K011577 OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S Ocu-Ease Optical Products, Inc. 2001-06-19 Traditional PDF ↗
K011316 BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T American Contact Lens, Inc. 2001-06-13 Traditional PDF ↗
K011234 BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L American Biocurve, Inc. 2001-06-13 Traditional PDF ↗
K011089 SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C Specialty Ultravision, Inc. 2001-05-23 Traditional PDF ↗
K004049 POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) Optech, Inc. 2001-05-23 Traditional PDF ↗
K010507 VISTAKON (METHAFILCON A) CONTACT LENSES Vistakon 2001-04-12 Traditional PDF ↗
K010114 ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) Johnson & Johnson Vision Care, Inc. 2001-04-11 Traditional PDF ↗
K010256 ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL Opti-Centre Laboratories 2001-03-26 Traditional PDF ↗
K010223 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) American Contact Lens, Inc. 2001-03-16 Traditional PDF ↗
K010218 VISTAKON (HEFILCON C) CONTACT LENSES Vistakon 2001-03-16 Traditional PDF ↗
K010126 PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) Cl-Tinters 2001-03-12 Traditional PDF ↗
K003861 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) Benz Research and Development Corp. 2001-03-08 Traditional PDF ↗
K004000 OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT Ocu-Ease Optical Products, Inc. 2001-02-21 Traditional PDF ↗
K003996 OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR Ocu-Ease Optical Products, Inc. 2001-02-21 Traditional PDF ↗
K003789 SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT Specialty Ultravision, Inc. 2001-02-21 Traditional PDF ↗
K001585 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE American Biocurve, Inc. 2001-02-13 Traditional PDF ↗
K003833 SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR Clearlab Pte , Ltd. 2001-02-13 Traditional PDF ↗
K003526 SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) Specialty Ultravision, Inc. 2001-02-12 Traditional PDF ↗
K003042 V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT Joe B. Goldberg, O.D. 2001-01-22 Traditional PDF ↗
K003136 OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS Ocular Sciences Puerto Rico, Inc. 2001-01-06 Traditional PDF ↗
K003170 RYTHMIC AND RYTHMIC UV Essilor Intl. 2000-12-15 Traditional PDF ↗
K003161 ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT Les Laboratoires Blanchard 2000-12-15 Traditional PDF ↗
K003071 GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Ciba Vision Corporation 2000-12-13 Special PDF ↗
K003079 SPECIALTY TINT SOFT CONTACT LENS Specialty Tint 2000-11-21 Traditional PDF ↗
K002966 OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR Ocu-Ease Optical Products, Inc. 2000-11-08 Traditional PDF ↗
K002408 AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS Unilens Corp., USA 2000-10-17 Traditional PDF ↗
K002625 METHAFILCON A CooperVision, Inc. 2000-09-13 Traditional PDF ↗
K002647 MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS Marietta Contact Lens Service 2000-09-13 Traditional PDF ↗
K001908 KONTUR 55 SOFT LENS Kontur Kontact Lens Co., Inc. 2000-08-18 Traditional PDF ↗
K001227 ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT Opti-Centre Laboratories 2000-06-29 Traditional PDF ↗
K001620 METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN Metro Optics of Austin, Inc. 2000-06-13 Traditional PDF ↗
K001584 METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT Medvice Consulting, Inc. 2000-06-13 Traditional PDF ↗
K001090 METHAFILCON A CooperVision, Inc. 2000-05-19 Traditional PDF ↗
K001089 POLYMACON CooperVision, Inc. 2000-05-19 Traditional PDF ↗
K993489 CRYSTAL CUSTOM TINTED SOFT CONTACT LENS Crystal Reflections, Int., Inc. 2000-04-14 Traditional PDF ↗
K000376 SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT Specialty Ultravision, Inc. 2000-03-21 Traditional PDF ↗
K000529 LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) The Lifestyle Co., Inc. 2000-03-21 Traditional PDF ↗
K000439 DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C Wesley Jessen Corp. 2000-03-20 Traditional PDF ↗
K994335 PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS Wesley Jessen Corp. 2000-03-20 Traditional PDF ↗
K000384 FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX CooperVision, Inc. 2000-03-06 Special PDF ↗
K994125 BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES Bausch & Lomb, Inc. 2000-03-03 Traditional PDF ↗
K994318 VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER Vistakon, Johnson & Johnson Vision Products, Inc. 2000-02-23 Traditional PDF ↗
K994324 ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER Vistakon, Johnson & Johnson Vision Products, Inc. 2000-02-23 Traditional PDF ↗
K993580 SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR Specialty Ultravision, Inc. 2000-02-02 Traditional PDF ↗
K993935 DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI Wesley Jessen Corp. 1999-12-21 Traditional PDF ↗
K983637 ACTIFRESH 400 LENS Hydron , Ltd. 1999-12-10 Traditional PDF ↗
K992264 OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS Ocular Sciences Puerto Rico, Inc. 1999-11-24 Traditional PDF ↗
K992950 CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS Prosthetic Soft Lens Corp. 1999-11-18 Traditional PDF ↗
K991015 LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) Lamda Polytech , Ltd. 1999-11-02 Traditional PDF ↗
K992692 EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS Benz Research and Development Corp. 1999-10-18 Traditional PDF ↗
K992466 OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR Ocu-Ease Optical Products, Inc. 1999-10-04 Traditional PDF ↗
K992589 RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY Opti-Centre Laboratories 1999-08-26 Traditional PDF ↗
K992500 CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS Cantor & Silver , Ltd. 1999-08-18 Traditional PDF ↗
K992339 COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS Colorsoft Laboratories Corp. 1999-08-16 Traditional PDF ↗
K984090 SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) Specialty Ultravision, Inc. 1999-07-07 Traditional PDF ↗
K992054 ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS Adventures IN Color Technology, Ltd. 1999-07-07 Traditional PDF ↗
K992010 W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) Westcon Contact Lens Co., Inc. 1999-06-29 Special PDF ↗
K991000 GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES Wesley Jessen Corp. 1999-06-28 Traditional PDF ↗
K991163 VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR Vistakon, Johnson & Johnson Vision Products, Inc. 1999-06-08 Traditional PDF ↗
K990815 COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS Colorsoft Laboratories Corp. 1999-06-03 Traditional PDF ↗
K991550 FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS Wesley Jessen Corp. 1999-05-14 Traditional PDF ↗
K990011 CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR Continental Soft Lens, Inc. 1999-05-11 Traditional PDF ↗
K984098 ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS Adventures IN Color Technology, Ltd. 1999-05-10 Traditional PDF ↗
K991134 ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR Vistakon, Johnson & Johnson Vision Products, Inc. 1999-05-06 Traditional PDF ↗
K990757 CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA Cantor & Silver , Ltd. 1999-04-21 Traditional PDF ↗
K990281 S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS Nissel , Ltd. 1999-04-16 Traditional PDF ↗
K983496 RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T Opti-Centre Laboratories 1999-03-29 Traditional PDF ↗
K990606 TETRAFILCON A CooperVision, Inc. 1999-03-15 Special PDF ↗
K983160 ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR Hydron , Ltd. 1999-02-18 Traditional PDF ↗
K984523 IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS Igel Vision Care Pte , Ltd. 1999-02-16 Traditional PDF ↗
K982947 BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS Ocular Sciences Puerto Rico, Inc. 1999-01-29 Traditional PDF ↗
K983912 VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER Vistakon, Johnson & Johnson Vision Products, Inc. 1999-01-26 Traditional PDF ↗
K984259 PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) Cl-Tinters 1999-01-21 Traditional PDF ↗
K984046 BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS Ocular Sciences Puerto Rico, Inc. 1999-01-21 Traditional PDF ↗
K982997 FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) Aspect Vision Care, Ltd. 1999-01-20 Traditional PDF ↗
K982988 PRECISION UV (VASURFILCON A) Wesley Jessen Corp. 1999-01-06 Traditional PDF ↗
K983773 BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS Benz Research and Development Corp. 1998-12-22 Traditional PDF ↗
K982344 DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS Wesley Jessen Corp. 1998-12-22 Traditional PDF ↗
K983278 OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) Alden Optical Labs., Inc. 1998-11-25 Traditional PDF ↗
K983894 BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS Bausch & Lomb, Inc. 1998-11-18 Traditional PDF ↗
K983021 METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC Metrosoft, Inc. 1998-11-13 Traditional PDF ↗
K982110 POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR Optech, Inc. 1998-11-06 Traditional PDF ↗
K983053 ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) Alden Optical Labs., Inc. 1998-10-21 Traditional PDF ↗
K982774 SOFT (HYDROPHILIC) CONTACT LENSES Cl-Tinters 1998-09-02 Traditional PDF ↗
K982904 ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS Les Laboratoires Blanchard 1998-09-01 Traditional PDF ↗
K974837 IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS Igel Vision Care Pte , Ltd. 1998-07-06 Traditional PDF ↗
K981779 CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT Cantor & Silver , Ltd. 1998-06-24 Traditional PDF ↗
K981252 OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) Alden Optical Labs., Inc. 1998-06-23 Traditional PDF ↗
K980649 PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS CooperVision, Inc. 1998-05-13 Traditional PDF ↗
K980634 FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) Aspect Vision Care, Ltd. 1998-04-22 Traditional PDF ↗
K974408 PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS Biocompatibles Eyewear, Inc. 1998-04-16 Traditional PDF ↗
K980554 ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) Alden Optical Labs., Inc. 1998-04-07 Traditional PDF ↗
K980818 POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) Stephen A. Dunn, Inc. 1998-03-30 Traditional PDF ↗
K980218 METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR Biocompatibles Eyewear, Inc. 1998-03-23 Traditional PDF ↗

Product code LPL · Class II · Ophthalmic. Data: openFDA.