FDA 510(k) Applications Submitted by MARTIN DALSING

FDA 510(k) Number Submission Date Device Name Applicant
K030167 01/16/2003 MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER CLEARLAB PTE LTD.
K010223 01/24/2001 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) AMERICAN CONTACT LENS, INC.
K100221 01/26/2010 INTELLIWAVE3 ART OPTICAL CONTACT LENS, INC.
K990264 01/27/1999 COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS METRO OPTICS OF AUSTIN, INC.
K010256 01/29/2001 ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL OPTI-CENTRE LABORATORIES
K100443 02/17/2010 DEFINITIVE, FLEXLENS - SILICONE HYDROGEL X-CEL CONTACTS, INC.
K100456 02/17/2010 CVUE ADVANCED DEFINITIVE UNILENS CORP., USA
K030593 02/25/2003 FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC X-CEL CONTACTS, A WALMAN CO.
K080512 02/25/2008 REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT METRO OPTICS OF AUSTIN, INC.
K080632 03/05/2008 CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS CLEARLAB SG PTE LTD.
K070628 03/07/2007 OPTIMUM GP (ROFLUFOCON A,B,C,D&E) DAILY WEAR CONTACT LENS. CONTAMAC LTD.
K990757 03/08/1999 CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA CANTOR & SILVER LTD.
K030748 03/10/2003 AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER CLEARLAB PTE LTD.
K990815 03/11/1999 COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS COLORSOFT LABORATORIES CORP.
K070767 03/20/2007 EYE SEE MULTIPURPOSE CONTACT LENS SOLUTION LAPIS LAZULI INTERNATIONAL NV
K991015 03/26/1999 LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) LAMDA POLYTECH LTD.
K981252 04/06/1998 OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) ALDEN OPTICAL LABS., INC.
K040914 04/08/2004 POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS EXERO PRODUCTS, INC.
K001227 04/17/2000 ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT OPTI-CENTRE LABORATORIES
K011234 04/23/2001 BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L AMERICAN BIOCURVE, INC.
K971515 04/25/1997 PROMED 38 SOFBLU (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FORM LENS BLANK) BIOMED DEVICES CORP.
K081178 04/25/2008 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES CONTAMAC LTD.
K011316 04/30/2001 BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T AMERICAN CONTACT LENS, INC.
K071203 05/01/2007 SEREINE EXTRA STRENGTH DAILY CLEANER FOR SILICONE HYDROGEL (SIHY) SOFT CONTACT LENSES OPTIKEM INTERNATIONAL, INC.
K051104 05/02/2005 EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION LAPIS LAZULI, NV
K121324 05/02/2012 AVT NATURASOFT ADVANCED VISION TECHNOLOGIES
K981779 05/20/1998 CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT CANTOR & SILVER LTD.
K001584 05/22/2000 METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT MED VICE CONSULTING, INC.
K001585 05/22/2000 BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE AMERICAN BIOCURVE, INC.
K121519 05/22/2012 ISIGHT C & E GP SPECIALISTS, INC.
K962121 05/31/1996 HORIZON/WESTHIN 55-G WESTCON CONTACT LENS CO., INC.
K051477 06/03/2005 MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) MI GWANG CONTACT LENS CO., LTD.
K991995 06/14/1999 SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS SOFTCHROME, INC.
K992054 06/17/1999 ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS ADVENTURES IN COLOR TECHNOLOGY, LTD.
K041700 06/22/2004 CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR CANTOR & NISSEL LTD.
K001962 06/27/2000 S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- BESCON CO., LTD.
K012132 07/09/2001 CHROMAGEN V3.0 READING AID SOFT CONTACT LENS CANTOR & NISSEL LTD.
K002099 07/11/2000 S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- BESCON CO., LTD.
K992339 07/13/1999 COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS COLORSOFT LABORATORIES CORP.
K022373 07/22/2002 CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS CANTOR & NISSEL LTD.
K032256 07/22/2003 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.
K992500 07/26/1999 CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS CANTOR & SILVER LTD.
K992589 08/02/1999 RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY OPTI-CENTRE LABORATORIES
K062332 08/10/2006 ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION ALTAIRE PHARMACEUTICALS, INC.
K052290 08/23/2005 AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS CLEARLAB PTE LTD.
K002647 08/24/2000 MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS MARIETTA CONTACT LENS SERVICE
K963512 08/30/1996 BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL BENZ RESEARCH AND DEVELOPMENT CORP.
K062548 08/30/2006 MODIFICATION TO OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD.
K983053 09/01/1998 ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) ALDEN OPTICAL LABS., INC.
K963744 09/17/1996 BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK) BENZ RESEARCH AND DEVELOPMENT CORP.
K983278 09/17/1998 OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) ALDEN OPTICAL LABS., INC.
K973597 09/22/1997 AL-47 (ISOFILCON) SOFT (SPHERICAL) DAILY WEAR CONTACT LENS MARTIN DALSING
K052606 09/22/2005 MARIETTA CONTACT LENS (POLYMACON), TINTED DAILY WEAR CONTACT LENS MARIETTA VISION
K013220 09/26/2001 HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) POLY VUE TECHNOLGIES, INC.
K954524 09/29/1995 W-55 (METHAFILON A) CONTACT LENS WESTCON CONTACT LENS CO., INC.
K102895 09/30/2010 ONE DAY FLAT PACK MENICON CO. LTD.
K983496 10/05/1998 RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T OPTI-CENTRE LABORATORIES
K023349 10/07/2002 CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD.
K973967 10/17/1997 AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK) ALDEN OPTICAL LABS., INC.
K983773 10/26/1998 BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS BENZ RESEARCH AND DEVELOPMENT CORP.
K133403 11/06/2013 FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS FIRESTONE OPTICS, INC.
K033594 11/13/2003 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD.
K984098 11/17/1998 ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS ADVENTURES IN COLOR TECHNOLOGY, LTD.
K023989 12/02/2002 CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD.
K023987 12/02/2002 CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD.
K024045 12/06/2002 CONTAFLEX GM3 49% (ACOFILCON B) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD.
K974599 12/09/1997 ULTRAVUE/P, ULTRALVUE/C (HIOXIFILCON B)) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & YINTED, LATHE-CUT FROM LENS) OPTI-CENTRE LABORATORIES
K003861 12/13/2000 BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) BENZ RESEARCH AND DEVELOPMENT CORP.
K994320 12/22/1999 CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES CANTOR & SILVER LTD.
K073621 12/26/2007 INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT ART OPTICAL CONTACT LENS, INC.
K004049 12/29/2000 POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) OPTECH, INC.
K111267 05/04/2011 CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) ABBCONCISE OPTICAL GROUP, LLC
K980554 02/13/1998 ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) ALDEN OPTICAL LABS., INC.
K970615 02/18/1997 PROMED 55-G SOFT DAILY WEAR CONTACT LENS BIOMED DEVICES CORP.
K973847 10/08/1997 AL-47 TORIC (ISOFILCON) SOFT (TORIC) DAILY WEAR CONTACT LENS MARTIN DALSING


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