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Ophthalmic

6,560 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
METHAFILCON A AND B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S068)CooperVision, Inc.2015-10-15
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S041)Alcon Laboratories, Inc.2015-10-13
ACRYSOF IQ ASPHERIC IOL WITH THE ULTRASERT PRELOADED DELIVERY SYSTEM (P930014/S084)Alcon Laboratories, Inc.2015-09-29
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P860047/S031)Bausch & Lomb, Inc.2015-09-25
HIGH CYLINDER POWER ACRYSOF IQ TORIC IOLS (P930014/S082)Alcon Laboratories, Inc.2015-09-18
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES (P060011/S008)Rayner Intraocular Lenses , Ltd.2015-09-09
ADATO SIL-OL 5000 SILICONE OIL (P910071/S015)Bausch & Lomb2015-08-28
LOTRAFILCON B SOFT (HYDROPHILIC) CONTACT LENSE (P010019/S040)Alcon Laboratories, Inc.2015-08-28
ACRYSOF INTRAOCULAR LENSES (P930014/S083)Alcon Laboratories, Inc.2015-08-26
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5 (P810031/S054)Johnson & Johnson Surgical Vision, Inc.2015-08-25
TECNIS TORIC 1-PIECE INTRAOCULAR LENS (P980040/S062)Johnson & Johnson Surgical Vision, Inc.2015-08-25
SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENS (N16895/S097)Bausch & Lomb, Inc.2015-08-19
ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S013)Glaukos Corporation2015-08-07
TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU (P980040/S058)Johnson & Johnson Surgical Vision, Inc.2015-07-31
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P780007/S054)CooperVision, Inc.2015-07-28
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S038)CooperVision, Inc.2015-07-28
BIOMEDICS 55 (OCUFILCON D) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P890023/S023)The Cooper Companies2015-07-28
TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080010/S011)Johnson & Johnson Surgical Vision, Inc.2015-07-24
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S016)Glaukos Corporation2015-07-21
ACRYSOF IQ SINGLE-PIECE IOL WITH THE ACRYSERT C DELIVERY SYSTME (P930014/S080)Alcon Laboratories, Inc.2015-07-20
ACRYSOF INTRAOCULAR LENSES, ACRYSOF RESTOR INTRAOCULAR LENSES (P930014/S081)Alcon Laboratories, Inc.2015-07-13
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK (P810031/S053)Johnson & Johnson Surgical Vision, Inc.2015-07-01
WAVELIGHT EX500 LASER SYSTEM (P020050/S021)Alcon Laboratories, Inc.2015-06-02
WAVELIGHT EX500 LASER SYSTEM (P030008/S019)Alcon Laboratories, Inc.2015-06-02
DUOVISC OPHTHALMIC VISCOSURGICAL DEVICE (WITH PROVISC IN LATEX-FREE PACKAGING CONFIGURATION ONLY) (P890047/S046)Alcon Research, Ltd.2015-06-02
VISCOAT & PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (LATEX-FREE PACKAGING CONFIGURATION ONLY FOR PROVISC) (P840064/S060)Alcon Laboratories2015-06-02
TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (P030002/S034)Bausch & Lomb, Inc.2015-06-02
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S039)Alcon Laboratories, Inc.2015-05-28
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES (P080011/S037)CooperVision, Inc.2015-05-21
SENSAR 1-PIECE INTRAOCULAR LENS (IOL) (P980040/S059)Johnson & Johnson Surgical Vision, Inc.2015-05-15
STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM (P930016/S044)Amo Manufacturing USA, LLC2015-05-06
WAVELIGHT EX500 LASER SYSTEM (P020050/S022)Alcon Laboratories, Inc.2015-05-05
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S051)Vistakon, Division of Johnson & Johnson Vision Car2015-05-05
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S077)Vistakon, Johnson & Johnson Vision Products, Inc.2015-05-05
WAVELIGHT EX500 LASER SYSTEM (P030008/S020)Alcon Laboratories, Inc.2015-05-05
ACRYSOF IQ POSTERIOR CHAMBER IOL (P930014/S079)Alcon Laboratories, Inc.2015-05-05
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S038)Alcon Laboratories, Inc.2015-05-05
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S017)Alcon Laboratories, Inc.2015-05-01
TECNIS ACRYLIC INTRAOCULAR LENS (P990080/S039)Johnson & Johnson Surgical Vision, Inc.2015-05-01
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S076)Vistakon, Johnson & Johnson Vision Products, Inc.2015-05-01
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S050)Vistakon, Division of Johnson & Johnson Vision Car2015-05-01
600C ASPHERIC INTRAOCULAR LENS (P060011/S005)Rayner Intraocular Lenses , Ltd.2015-05-01
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S061)Johnson & Johnson Surgical Vision, Inc.2015-05-01
ALLEGRO TOPOLYZER VARIO (P020050/S019)Alcon Laboratories, Inc.2015-05-01
TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS (P880081/S039)Johnson & Johnson Surgical Vision, Inc.2015-05-01
ACRYSOF(R) IQ TORIC INTRAOCULAR LENS (P930014/S074)Alcon Laboratories, Inc.2015-04-30
ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL) (P910056/S020)Bausch & Lomb, Inc.2015-04-29
PERFLUORON (P950018/S018)Alcon Laboratories2015-04-22
TECNIS 1- PIECE IOL WITH TECNIS ITEC, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC, AND TECNIS TORIC 1-PIECE IOL (P980040/S060)Johnson & Johnson Surgical Vision, Inc.2015-04-17
TECNIS TORIC 1-PIECE IOL, MODEL ZCT375 (P980040/S057)Johnson & Johnson Surgical Vision, Inc.2015-04-17
KAMRA INLAY (P120023)Corneagen2015-04-17
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S036)CooperVision, Inc.2015-04-15
EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS (P100016/S002)Carl Zeiss Meditec Production, LLC2015-04-13
ACRYSOF IQ RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS (P040020/S050)Alcon Research, Ltd.2015-04-13
VISCOAT OPHTHALMIC VISCOSURICAL DEVICE, DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S059)Alcon Laboratories2015-04-10
RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES (P060011/S006)Rayner Intraocular Lenses , Ltd.2015-04-09
TRULIGN TORIC WEB-BASED TORIC CALCULATOR (P030002/S033)Bausch & Lomb, Inc.2015-04-09
LOTRAFILCON A SOFT CONTACT LENSES (P010019/S037)Alcon Laboratories, Inc.2015-04-02
HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE (P110007/S006)Johnson & Johnson Surgical Vision, Inc.2015-04-02
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, AND HEALON5 (P810031/S052)Johnson & Johnson Surgical Vision, Inc.2015-04-02
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P030008/S018)Alcon Laboratories, Inc.2015-03-31
WAVELIGHT EX500 EXCIMER LASER SYSTEM (P020050/S020)Alcon Laboratories, Inc.2015-03-31
NIDEK EXCLAIMER LASER SYSTEM EC-5000 (P970053/S015)Nidek Co., Ltd.2015-03-30
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S014)Glaukos Corporation2015-03-24
PURE VISION (BALAFILCON A)VISIBILITY TINTED CONTACT LENS (P980006/S024)Bausch & Lomb, Inc.2015-03-23
AKREOS INTRAOCULAR LENS (P060022/S021)Bausch & Lomb, Inc.2015-03-20
ACRYSOF RESTOR INTRAOCULAR LENSES (P040020/S056)Alcon Research, Ltd.2015-03-19
ACRYSOF INTRAOCULAR LENSES (P930014/S078)Alcon Laboratories, Inc.2015-03-19
TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM (P980040/S056)Johnson & Johnson Surgical Vision, Inc.2015-03-17
BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL (P080011/S035)CooperVision, Inc.2015-03-11
ACRYSOF ASPHERIC UV ABSORBING INTRAOCULAR LENSES (IOLS) (P930014/S076)Alcon Laboratories, Inc.2015-03-10
OCUCOAT OVD (P860047/S029)Bausch & Lomb, Inc.2015-03-03
ACRYSOF IQ TORIC IOLS (P930014/S077)Alcon Laboratories, Inc.2015-02-17
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS (P060022/S020)Bausch & Lomb, Inc.2015-02-03
VISIONCARE IMPLANTABLE MINIATURE TELESCOPE (P050034/S015)Samsara Vision, Inc.2015-01-27
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S049)Vistakon, Division of Johnson & Johnson Vision Car2015-01-22
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S034)CooperVision, Inc.2015-01-22
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S075)Vistakon, Johnson & Johnson Vision Products, Inc.2015-01-22
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S033)CooperVision, Inc.2015-01-21
WAVELIGHT EX500 LASER SYSTEM (P020050/S018)Alcon Laboratories, Inc.2015-01-20
WAVELIGHT EX500 LASER SYSTEM (P030008/S016)Alcon Laboratories, Inc.2015-01-20
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S048)Vistakon, Division of Johnson & Johnson Vision Car2015-01-16
SOFTEC HD; SOFTEC I; SOFTEC HD PS AND SOFTEC HDO IOLS (P090022/S024)Lenstec, Inc.2015-01-15
COMFILCON A EXTENDED WEAR-LENSES (P080011/S028)CooperVision, Inc.2015-01-09
OCUFILCON D EXTENDED-WEAR LENSES (P890023/S021)The Cooper Companies2015-01-09
POLYMACON EXTENDED-WEAR LENSES (P780007/S053)CooperVision, Inc.2015-01-09
TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22 (P980040/S055)Johnson & Johnson Surgical Vision, Inc.2014-12-31
VISIAN IMPLANTABLE COLLAMER LENSES (P030016/S027)STAAR Surgical Company2014-12-22
WAVE LIGHT EX500 LASER SYSTEM (P020050/S017)Alcon Laboratories, Inc.2014-12-17
BIOFINITY (COMFLICON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S032)CooperVision, Inc.2014-12-17
WAVE LIGHT EX500 LASER SYSTEM (P030008/S015)Alcon Laboratories, Inc.2014-12-17
TECNIS 1 PIECE IOL WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM); TECNIS MULTIFOCAL 1 PIECE IOL WITH THE TECNIS ITEC P (P980040/S054)Johnson & Johnson Surgical Vision, Inc.2014-12-17
TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS (IOL) (P980040/S049)Johnson & Johnson Surgical Vision, Inc.2014-12-17
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S012)Glaukos Corporation2014-12-16
DUOVISC AND DISCOVISC (P840064/S058)Alcon Laboratories2014-12-12
PROVISC (P890047/S045)Alcon Research, Ltd.2014-12-12
CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENS (IOLS) (P030002/S032)Bausch & Lomb, Inc.2014-12-04
EQUATE ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENSES, EQUATE TORIC (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LE (P890023/S022)The Cooper Companies2014-11-21
NIDEK EXCIMER LASER SYSTEM EC-5000 (P970053/S013)Nidek Co., Ltd.2014-11-21
TECNIS 1-PIECE LENS MODEL ZCB00; TECNIS MULTIFOCAL 1-PIECE LENS MODEL ZBM00, SENSAR 1-PIECE LENS MODEL AAB00; TECNIS 1-P (P980040/S052)Johnson & Johnson Surgical Vision, Inc.2014-11-21
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