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486 FDA 510(k) clearances · Product code

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RecordFirmDate
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS (K011072)Gelflex2001-08-24
TORIC LITE LENS (K011256)Soflex Contact Lens Industries , Ltd.2001-07-17
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY- (K001962)Bescon Co., Ltd.2001-07-09
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY- (K002099)Bescon Co., Ltd.2001-07-09
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D) (K011542)Specialty Ultravision, Inc.2001-06-26
OCU-FLEX 55 SPHERICAL, TORIC,THIN ZONE TORIC,ASPHERICAL,TORIC ASPHERICAL AND THIN ZONE TORIC ASPHERICAL (METHAFILCON A)S (K011577)Ocu-Ease Optical Products, Inc.2001-06-19
BIOCURVE SOFT (HIOXIFILCON B) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING L (K011234)American Biocurve, Inc.2001-06-13
BIOCURVE SOFT (HIOXIFILCOM A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND BLUE VISIBILITY-HANDLING T (K011316)American Contact Lens, Inc.2001-06-13
SPECIALITY 42 UV (HEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALITY 42 UV TORIC (HEFILCON A) SOFT C (K011089)Specialty Ultravision, Inc.2001-05-23
POLVUE MULTIFOCAL (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND VISIBILITY TINTED, FULLY CAST-MOLDED LENS) (K004049)Optech, Inc.2001-05-23
VISTAKON (METHAFILCON A) CONTACT LENSES (K010507)Vistakon2001-04-12
ACUVUE 2 BRAND (ETAFILCON A) CONTACT LENS, WITH UV BLOCKER TINTED (TO MASK OR ENHANCE THE NATURAL IRIS COLOR) (K010114)Johnson & Johnson Vision Care, Inc.2001-04-11
ULTRAVUE/P 2000T, ULTRAVUE/C 2000T (HIOXIFILCON B) SOFT (MULTIFOCAL TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBIL (K010256)Opti-Centre Laboratories2001-03-26
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K010223)American Contact Lens, Inc.2001-03-16
VISTAKON (HEFILCON C) CONTACT LENSES (K010218)Vistakon2001-03-16
PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K010126)Cl-Tinters2001-03-12
BENZ-MF (VISIBILITY HANGLING TINT) (METHAFILCON A) SOFT DAILY WEAR CONTACT LENS (LATHE-CUT) (K003861)Benz Research and Development Corp.2001-03-08
OCU-FLEX-49 THIN ZONE TORIC AND THIN Z0NE TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (LATHE-CUT (K004000)Ocu-Ease Optical Products, Inc.2001-02-21
OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR (K003996)Ocu-Ease Optical Products, Inc.2001-02-21
SPECIALITY 56 UV (HEFILCON C) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR; SPECIALITY 56 UV TORIC (HEFILCON C) SOFT (K003789)Specialty Ultravision, Inc.2001-02-21
SPECIALTY 55 & MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K003833)Clearlab Pte , Ltd.2001-02-13
BIOCURVE SOFT (METHAFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR & BLUE VISIBILITY TINT, LATHE (K001585)American Biocurve, Inc.2001-02-13
SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON) (K003526)Specialty Ultravision, Inc.2001-02-12
V/X ASPHERIC TORIC MULTIFOCAL (POLYMACON) SOFT (HYDROPHILIC) LENSES WITH A CLEAR OR BLUE VISIBILITY TINT (K003042)Joe B. Goldberg, O.D.2001-01-22
OCULAR SCIENCES, INC. BIOMEDICS 52 (OCUFILCON D) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K003136)Ocular Sciences Puerto Rico, Inc.2001-01-06
ESSTECH MULTI TORIC ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (CLEAR AND TINT (K003161)Les Laboratoires Blanchard2000-12-15
RYTHMIC AND RYTHMIC UV (K003170)Essilor Intl.2000-12-15
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K003071)Ciba Vision Corporation2000-12-13
SPECIALTY TINT SOFT CONTACT LENS (K003079)Specialty Tint2000-11-21
OCU-FLEX-49 SPHERICAL, TORIC, ASPHERICAL AND TORIC ASPHERICAL (HIOXIFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR (K002966)Ocu-Ease Optical Products, Inc.2000-11-08
AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS (K002408)Unilens Corp., USA2000-10-17
METHAFILCON A (K002625)CooperVision, Inc.2000-09-13
MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS (K002647)Marietta Contact Lens Service2000-09-13
KONTUR 55 SOFT LENS (K001908)Kontur Kontact Lens Co., Inc.2000-08-18
ULTRA VUE 55/P & C (METHAFILCON A) SOFT (MULTIFOCAL, SPHERICAL, & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILIT (K001227)Opti-Centre Laboratories2000-06-29
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN (K001620)Metro Optics of Austin, Inc.2000-06-13
METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT (K001584)Medvice Consulting, Inc.2000-06-13
METHAFILCON A (K001090)CooperVision, Inc.2000-05-19
POLYMACON (K001089)CooperVision, Inc.2000-05-19
CRYSTAL CUSTOM TINTED SOFT CONTACT LENS (K993489)Crystal Reflections, Int., Inc.2000-04-14
SPECIALTY 42 (HEFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR, SPECIALTY T-42 TORIC (HEFILCON A) HYDROPHILIC CONTACT (K000376)Specialty Ultravision, Inc.2000-03-21
LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED) (K000529)The Lifestyle Co., Inc.2000-03-21
PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS (K994335)Wesley Jessen Corp.2000-03-20
DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C (K000439)Wesley Jessen Corp.2000-03-20
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX (K000384)CooperVision, Inc.2000-03-06
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES (K994125)Bausch & Lomb, Inc.2000-03-03
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994324)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994318)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K993580)Specialty Ultravision, Inc.2000-02-02
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI (K993935)Wesley Jessen Corp.1999-12-21
ACTIFRESH 400 LENS (K983637)Hydron , Ltd.1999-12-10
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K992264)Ocular Sciences Puerto Rico, Inc.1999-11-24
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS (K992950)Prosthetic Soft Lens Corp.1999-11-18
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K991015)Lamda Polytech , Ltd.1999-11-02
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS (K992692)Benz Research and Development Corp.1999-10-18
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (K992466)Ocu-Ease Optical Products, Inc.1999-10-04
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY (K992589)Opti-Centre Laboratories1999-08-26
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS (K992500)Cantor & Silver , Ltd.1999-08-18
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS (K992339)Colorsoft Laboratories Corp.1999-08-16
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) (K984090)Specialty Ultravision, Inc.1999-07-07
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS (K992054)Adventures IN Color Technology, Ltd.1999-07-07
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) (K992010)Westcon Contact Lens Co., Inc.1999-06-29
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES (K991000)Wesley Jessen Corp.1999-06-28
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991163)Vistakon, Johnson & Johnson Vision Products, Inc.1999-06-08
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS (K990815)Colorsoft Laboratories Corp.1999-06-03
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS (K991550)Wesley Jessen Corp.1999-05-14
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K990011)Continental Soft Lens, Inc.1999-05-11
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS (K984098)Adventures IN Color Technology, Ltd.1999-05-10
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991134)Vistakon, Johnson & Johnson Vision Products, Inc.1999-05-06
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA (K990757)Cantor & Silver , Ltd.1999-04-21
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K990281)Nissel , Ltd.1999-04-16
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T (K983496)Opti-Centre Laboratories1999-03-29
TETRAFILCON A (K990606)CooperVision, Inc.1999-03-15
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR (K983160)Hydron , Ltd.1999-02-18
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS (K984523)Igel Vision Care Pte , Ltd.1999-02-16
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS (K982947)Ocular Sciences Puerto Rico, Inc.1999-01-29
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER (K983912)Vistakon, Johnson & Johnson Vision Products, Inc.1999-01-26
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K984259)Cl-Tinters1999-01-21
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS (K984046)Ocular Sciences Puerto Rico, Inc.1999-01-21
FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) (K982997)Aspect Vision Care, Ltd.1999-01-20
PRECISION UV (VASURFILCON A) (K982988)Wesley Jessen Corp.1999-01-06
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS (K982344)Wesley Jessen Corp.1998-12-22
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS (K983773)Benz Research and Development Corp.1998-12-22
OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) (K983278)Alden Optical Labs., Inc.1998-11-25
BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS (K983894)Bausch & Lomb, Inc.1998-11-18
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC (K983021)Metrosoft, Inc.1998-11-13
POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR (K982110)Optech, Inc.1998-11-06
ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) (K983053)Alden Optical Labs., Inc.1998-10-21
SOFT (HYDROPHILIC) CONTACT LENSES (K982774)Cl-Tinters1998-09-02
ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS (K982904)Les Laboratoires Blanchard1998-09-01
IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS (K974837)Igel Vision Care Pte , Ltd.1998-07-06
CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT (K981779)Cantor & Silver , Ltd.1998-06-24
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) (K981252)Alden Optical Labs., Inc.1998-06-23
PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS (K980649)CooperVision, Inc.1998-05-13
FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K980634)Aspect Vision Care, Ltd.1998-04-22
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS (K974408)Biocompatibles Eyewear, Inc.1998-04-16
ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) (K980554)Alden Optical Labs., Inc.1998-04-07
POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) (K980818)Stephen A. Dunn, Inc.1998-03-30
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (K980218)Biocompatibles Eyewear, Inc.1998-03-23
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS (K974780)Bausch & Lomb, Inc.1998-03-11
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