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Ophthalmic

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

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RecordFirmDate
iDESIGN Refractive Studio; STAR Excimer Laser System (P930016/S055)Amo Manufacturing USA, LLC2019-01-29
comfilcon A (P080011/S088)CooperVision, Inc.2019-01-28
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S104)Vistakon, Division of Johnson & Johnson Vision Car2019-01-16
TECNIS 3-Piece Acrylic Monofocal (P990080/S047)Johnson & Johnson Surgical Vision, Inc.2019-01-15
SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Exten (P980040/S097)Johnson & Johnson Surgical Vision, Inc.2019-01-15
VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses (P040045/S103)Vistakon, Division of Johnson & Johnson Vision Car2019-01-15
TECNIS 3-Poece Multifocal (P080010/S017)Johnson & Johnson Surgical Vision, Inc.2019-01-15
SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Exten (P980040/S096)Johnson & Johnson Surgical Vision, Inc.2019-01-15
TECNIS 3-Piece Acrylic Monofocal (P990080/S048)Johnson & Johnson Surgical Vision, Inc.2019-01-15
TECNIS 3-Poece Multifocal (P080010/S016)Johnson & Johnson Surgical Vision, Inc.2019-01-15
Biofinity XR Toric (comfilcon A) (P080011/S086)CooperVision, Inc.2019-01-11
Lotrafilcon A and Lotrafilcon B soft contact lenses for daily and extended wear (P010019/S070)Alcon Laboratories, Inc.2018-12-27
Glaukos Corporation iStent Trabecular Micro-Bypass Stent System (P080030/S022)Glaukos Corporation2018-12-18
AquaTech Plus Premium multifocal (P080011/S082)CooperVision, Inc.2018-12-14
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S118)Alcon Laboratories, Inc.2018-12-14
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S086)Alcon Research, Ltd.2018-12-14
SENSAR 1-Piece IOL; TECNIS 1-Piece IOL; TECNIS 1-Piece OptiBlue IOL; Preloaded TECNIS 1-Piece IOL (P980040/S094)Johnson & Johnson Surgical Vision, Inc.2018-12-13
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S117)Alcon Laboratories, Inc.2018-12-07
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S085)Alcon Research, Ltd.2018-12-07
Biofinity (Comfilcon A) (P080011/S084)CooperVision, Inc.2018-11-30
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S102)Vistakon, Division of Johnson & Johnson Vision Car2018-11-29
polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S059)CooperVision, Inc.2018-11-23
tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S039)CooperVision, Inc.2018-11-23
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S069)CooperVision, Inc.2018-11-23
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S030)The Cooper Companies2018-11-23
methafilcon A and methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S077)CooperVision, Inc.2018-11-23
Biofinity Sphere (P080011/S083)CooperVision, Inc.2018-11-16
Rayner C-Flex 570, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses (P060011/S014)Rayner Intraocular Lenses , Ltd.2018-11-14
TECNIS Symfony Toric IOL (P980040/S093)Johnson & Johnson Surgical Vision, Inc.2018-11-14
enVista Hydrophobic Acrylic Intraocular Lens (P910056/S035)Bausch & Lomb, Inc.2018-11-06
AcrySof Intraocular Lenses (P930014/S116)Alcon Laboratories, Inc.2018-11-01
AcrySof ReSTOR Intraocular Lenses (P040020/S084)Alcon Research, Ltd.2018-11-01
enVista One Piece Hydrophobic Acrylic Intraocular LEns (IOL) (P910056/S034)Bausch & Lomb, Inc.2018-10-31
WaveLight EX500 Excimer Laser System (P030008/S027)Alcon Laboratories, Inc.2018-10-26
WaveLight EX500 Excimer Laser System (P020050/S031)Alcon Laboratories, Inc.2018-10-26
Artisan Myopia (P030028/S006)Ophtec BV2018-10-23
BIOFINITY (COMFILCON A) (P080011/S081)CooperVision, Inc.2018-10-15
AcrySof IQ ReSTOR Intraocular Lenses (P040020/S083)Alcon Research, Ltd.2018-10-11
iSert Preloaded System, iSymm Intraocular Lens (AF-1), Clarisert Preloaded IOL System (P080004/S019)Hoya Surgical Optics, Inc.2018-10-11
ACRYSOF IQ RESTOR APODIZED + 3.0D MULTIFOCAL TORIC INTRAOCULAR LENS (P040020/S068)Alcon Research, Ltd.2018-10-11
AcrySof Single Piece Intraocular Lenses (P930014/S115)Alcon Laboratories, Inc.2018-10-11
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S113)Alcon Laboratories, Inc.2018-10-04
VisuMax Femtosecond Laser (P150040/S003)Carl Zeiss Meditec, Inc.2018-10-04
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S082)Alcon Research, Ltd.2018-10-04
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S081)Alcon Research, Ltd.2018-10-04
AcrySof Posterior Chamber Single Piece Intraocular Lens (P930014/S114)Alcon Laboratories, Inc.2018-10-04
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S100)Vistakon, Johnson & Johnson Vision Products, Inc.2018-10-03
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S101)Vistakon, Division of Johnson & Johnson Vision Car2018-10-03
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S031)The Cooper Companies2018-10-02
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S074)CooperVision, Inc.2018-10-02
polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S061)CooperVision, Inc.2018-10-02
Sensar/Tecnis 1-Piece IOL, Tecnis Toric IOL, Tecnis Symfony Extended Range of Vision IOL, Tecnis Symfony Toric Extended (P980040/S089)Johnson & Johnson Surgical Vision, Inc.2018-09-26
CT LUCIA 202 and CT LUCIA 602 intraocular lenses (P100016/S006)Carl Zeiss Meditec Production, LLC2018-09-20
Visian Toric ICL (IMPLANTABLE COLLAMER LENS) (P030016/S001)STAAR Surgical Company2018-09-13
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S033)The Cooper Companies2018-09-07
Softec HD/ HD PS, Softec I, Softec HDO, Softec HDM IOLs (P090022/S035)Lenstec, Inc.2018-09-06
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses (P010019/S068)Alcon Laboratories, Inc.2018-08-28
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S080)CooperVision, Inc.2018-08-27
ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL) (P030028/S004)Ophtec BV2018-08-20
ARTISAN/VERISYSE MYOPIA PHAKIC INTRAOCULAR LENS (P030028/S005)Ophtec BV2018-08-20
AcrySof ReSTOR IOLs (P040020/S080)Alcon Research, Ltd.2018-08-16
CyPass System, CyPass Ultra System, CyPass Micro-Stent (P150037/S011)Alcon Research, Ltd.2018-08-13
HYDRUS MICROSTENT (P170034)Alcon Research, LLC2018-08-10
WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P030008/S026)Alcon Laboratories, Inc.2018-08-09
WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P020050/S030)Alcon Laboratories, Inc.2018-08-09
Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys; Biofinity Toric and Biofinity XR Toric; Biofinity Multifoca (P080011/S078)CooperVision, Inc.2018-08-09
Air Optix Aqua for Astigmatism / Aqua Multifocal / plus Hydraglyde / plus Hydraglyde Multifocal / plus Hydraglyde for As (P010019/S067)Alcon Laboratories, Inc.2018-08-08
Akreos Intraocular Lens (P060022/S024)Bausch & Lomb, Inc.2018-08-07
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S077)CooperVision, Inc.2018-08-07
Preset Tips (P080004/S017)Hoya Surgical Optics, Inc.2018-08-06
enVista Hydrophobic Arcylic Intraocular Lens (P910056/S031)Bausch & Lomb, Inc.2018-08-06
SofLEns 38 (polymacon) Visibility Tinted Contact Lens (N16895/S102)Bausch & Lomb, Inc.2018-08-03
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses, Biomedics 55 Sphere, Biomedics Toric (P890023/S034)The Cooper Companies2018-08-01
AcrySof Posteriior Chamber Single Piece Intraocular Lenses (P930014/S112)Alcon Laboratories, Inc.2018-07-31
AcrySof IQ ReStor Posterior Chamber Intraocular Lenses (P040020/S079)Alcon Research, Ltd.2018-07-31
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S100)Vistakon, Division of Johnson & Johnson Vision Car2018-07-30
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses (P010019/S066)Alcon Laboratories, Inc.2018-07-24
TECNIS 1-Piece IOL with TECNIS iTEC Preloaded Delivery System (PCB00), TECNIS Multifocal 1-Piece IOL with TECNIS iTEC Pr (P980040/S092)Johnson & Johnson Surgical Vision, Inc.2018-07-24
CyPass Ultra System (P150037/S010)Alcon Research, Ltd.2018-07-23
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch & Lomb, Vision Shaping Treatment (P010062/S011)Bausch & Lomb2018-07-19
TECNIS SYMFONY TORIC EXTENDED RANGE OF VISION INTRAOCULAR LENSES (IOLS), MODELS ZXT150, ZXT225,ZXT300, AND ZT375 (P980040/S072)Johnson & Johnson Surgical Vision, Inc.2018-07-10
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S099)Vistakon, Johnson & Johnson Vision Products, Inc.2018-07-10
Enhanced enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S030)Bausch & Lomb, Inc.2018-07-10
Rayner C-flex 570C, C-Flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S012)Rayner Intraocular Lenses , Ltd.2018-07-05
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S076)CooperVision, Inc.2018-07-02
tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S040)CooperVision, Inc.2018-06-29
methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S079)CooperVision, Inc.2018-06-29
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S099)Vistakon, Division of Johnson & Johnson Vision Car2018-06-28
VISCOAT/DUOVISC Ophthalmic Viscoelastic System (P840064/S069)Alcon Laboratories2018-06-28
Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S032)The Cooper Companies2018-06-27
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043)Glaukos Corporation2018-06-21
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S098)Vistakon, Division of Johnson & Johnson Vision Car2018-06-19
iDESIGNRefractive Studio, STAR Excimer Laser System (P930016/S053)Amo Manufacturing USA, LLC2018-06-15
TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOLs, TECNIS Toric 1-Piece IOLs, TECNIS Toric (P980040/S090)Johnson & Johnson Surgical Vision, Inc.2018-06-12
SofLens 38 (polymacon) Visibility Tinted Contact Lens (N16895/S101)Bausch & Lomb, Inc.2018-06-11
TECNIS Symfony Toric Extended Range of Vision IOL and TECNIS Toric 1-Piece IOL (P980040/S091)Johnson & Johnson Surgical Vision, Inc.2018-06-11
enVista One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model MX60T) (P910056/S027)Bausch & Lomb, Inc.2018-06-08
Silikon 1000 Endotamponade (P950008/S014)Alcon2018-06-07
Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S060)CooperVision, Inc.2018-06-01
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses, Biofinity Sphere/Biofinity XR Sphere, Biofinity Energys, Bi (P080011/S075)CooperVision, Inc.2018-06-01
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