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Ophthalmic

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

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RecordFirmDate
Glaukos® Corporation iStent inject® W Trabecular Micro-Bypass System (P170043/S018)Glaukos Corporation2023-12-20
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S062)Alcon Research, Ltd.2023-12-18
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S083)Alcon Laboratories2023-12-18
Clareon PanOptix Pro Trifocal Intraocular Lens (IOL), Clareon PanOptix Pro Trifocal Toric IOLs, Clareon PanOptix Pro Tr (P190018/S029)Alcon Laboratories, LLC2023-12-18
Lotrafilcon B soft contact lenses for daily and extended wear (P010019/S084)Alcon Laboratories, Inc.2023-12-15
Perfluoron (P950018/S027)Alcon Laboratories2023-12-12
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S133)Vistakon, Division of Johnson & Johnson Vision Car2023-12-06
Perfluoron (P950018/S026)Alcon Laboratories2023-11-28
TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System (P990027/S021)Technolas Perfect Vision GmbH2023-11-22
Perfluoron (P950018/S025)Alcon Laboratories2023-11-21
Rotlex IOLA MFD (P200020/S004)Lenstec, Inc.2023-11-09
IC-8 Apthera intraocular lens (IOL) (P210005/S006)Acu Focus, Inc.2023-10-30
PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S032)Alcon Laboratories2023-10-25
iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231, IPure™ Preloaded IOL System / Model B1PC (Clear (P080004/S047)Hoya Surgical Optics, Inc.2023-10-25
PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S050)Alcon Laboratories2023-10-25
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S147)Alcon Laboratories, Inc.2023-10-25
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S028)Alcon Laboratories, LLC2023-10-24
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S146)Alcon Laboratories, Inc.2023-10-24
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S106)Alcon Research, Ltd.2023-10-24
Light Adjustable Lens, Light Delivery Device (P160055/S032)Rxsight, Inc.2023-10-24
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S132)Vistakon, Division of Johnson & Johnson Vision Car2023-10-23
Silikon 1000 (P950008/S022)Alcon2023-10-20
TECNIS Simplicity Delivery System, SmartLOAD Delivery Technology, TECNIS iTec Preloaded Delivery System (P980040/S163)Johnson & Johnson Surgical Vision, Inc.2023-10-19
iDesign Refractive Studio (P930016/S063)Amo Manufacturing USA, LLC2023-10-16
CT LUCIA 602, CT LUCIA 202 (P100016/S019)Carl Zeiss Meditec Production, LLC2023-10-10
CT LUCIA 621P (P100016/S017)Carl Zeiss Meditec Production, LLC2023-10-02
Biofinity Sphere, Biofinity Torie, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (comfilcon A) Soft (Hydr (P080011/S157)CooperVision, Inc.2023-09-28
TECNIS Foldable Acrylic IOL with OptiEdge (P990080/S059)Johnson & Johnson Surgical Vision, Inc.2023-09-27
TECNIS Multifocal 3-Piece, TECNIS Foldable Acrylic IOL with OptiEdge (P080010/S024)Johnson & Johnson Surgical Vision, Inc.2023-09-27
SENSAR® Soft Acrylic Posterior Chamber IOL (P980040/S165)Johnson & Johnson Surgical Vision, Inc.2023-09-27
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S031)Rxsight, Inc.2023-09-21
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon® PRO, Healon GV® PRO, Healon5® PRO and Healon® Duet PRO (P810031/S073)Johnson & Johnson Surgical Vision, Inc.2023-09-19
Silikon 1000 (P950008/S019)Alcon2023-09-15
MORCHER® Capsular Tension Rings (P010059/S011)Morcher GmbH2023-09-06
MORCHER Capsular Tension Ring, EYEJET CTR, MORCHER Injector (P010059/S007)Morcher GmbH2023-09-06
Rayner C-flex 570, C-flex Aspheric 970, 600 Aspheric Intraocular lenses, RayOne Aspheric RA0600, RayOne Spheric RAO100 a (P060011/S034)Rayner Intraocular Lenses , Ltd.2023-09-05
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic (P840064/S081)Alcon Laboratories2023-09-05
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgic (P840064/S082)Alcon Laboratories2023-08-31
Perfluoron (P950018/S024)Alcon Laboratories2023-08-29
Hydrus Microstent Delivery System (P170034/S010)Alcon Research, LLC2023-08-24
WaveLight EX500 Laser System (P030008/S037)Alcon Laboratories, Inc.2023-08-23
WaveLight EX500 Laser System (P020050/S041)Alcon Laboratories, Inc.2023-08-23
SENSAR® 1-piece IOL, AAB00, TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, DCB00, TECNIS® 1-Piece OptiBlue (P980040/S162)Johnson & Johnson Surgical Vision, Inc.2023-08-21
enVista Hydrophobic Acrylic Intraocular Lens (P910056/S051)Bausch & Lomb, Inc.2023-08-21
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S111)Vistakon, Johnson & Johnson Vision Products, Inc.2023-08-21
Biofinity Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys, Biofinity Sphere XR (P080011/S156)CooperVision, Inc.2023-08-21
MORCHER ® EYEJET ® CTR (P010059/S010)Morcher GmbH2023-08-17
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), (P840064/S080)Alcon Laboratories2023-08-15
VisuMax Femtosecond Laser Accessory– Treatment Pack (P150040/S014)Carl Zeiss Meditec, Inc.2023-08-15
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S061)Alcon Research, Ltd.2023-08-15
Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric (P220007/S002)Alcon Laboratories, Inc.2023-08-11
Clareon Intraocular Lenses with the AutonoMe™ Delivery System (P190018/S026)Alcon Laboratories, LLC2023-08-10
Biofinity Sphere (P080011/S155)CooperVision, Inc.2023-08-09
Silikon 1000 (P950008/S016)Alcon2023-08-02
IC-8 Apthera Intraocular Lens (P210005/S005)Acu Focus, Inc.2023-07-31
PERFLUORON™ (P950018/S023)Alcon Laboratories2023-07-17
iStent inject® W Trabecular Micro-Bypass System (P170043/S017)Glaukos Corporation2023-07-14
iStent inject® W Trabecular Micro-Bypass System (P170043/S016)Glaukos Corporation2023-07-13
Light Adjustable Lens, Light Delivery Device (P160055/S028)Rxsight, Inc.2023-06-29
Silikon 1000 (P950008/S021)Alcon2023-06-26
iSert Preloaded IOL System, IPure™ Preloaded IOL System (P080004/S045)Hoya Surgical Optics, Inc.2023-06-22
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S044)Bausch & Lomb, Inc.2023-06-22
Precision7, Precision7 for Astigmatism, Precision7 Multifocal, and Precision7 Multifocal Toric (P220007/S001)Alcon Laboratories, Inc.2023-06-21
ACUVUE® AbilitiTM Overnight; ACUVUE® AbilitiTM Overnight Therapeutic Lenses For Myopia Management; Menicon Z Night (Ti (P990018/S010)Menicon Co, Ltd.2023-06-16
Clareon Intraocular Lenses with the AutonoMe™ Delivery System (P190018/S025)Alcon Laboratories, LLC2023-06-13
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S145)Alcon Laboratories, Inc.2023-06-13
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S105)Alcon Research, Ltd.2023-06-13
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S019)CooperVision, Inc.2023-06-09
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S018)CooperVision, Inc.2023-06-09
WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P030008/S036)Alcon Laboratories, Inc.2023-06-02
WaveLight EX500 Laser System with Patient Bed Swivel 1125 (P020050/S040)Alcon Laboratories, Inc.2023-06-02
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S024)Alcon Laboratories, LLC2023-05-31
OcuCoat 1ml syringe, OcuCoat ml syrince 6 pack, OcuCoat 2ml syringe (P860047/S035)Bausch & Lomb, Inc.2023-05-31
TECNIS Next-Generation Presbyopia-Correcting IOL (P980040/S156)Johnson & Johnson Surgical Vision, Inc.2023-05-23
RxSight Light Adjustable Lens (LAL), Light Delivery Device (LDD) (P160055/S029)Rxsight, Inc.2023-05-18
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S131)Vistakon, Division of Johnson & Johnson Vision Car2023-05-17
CT LUCIA 621P (P100016/S016)Carl Zeiss Meditec Production, LLC2023-05-09
iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure™ Preloaded IOL System/ Model B1PC (Clear (P080004/S046)Hoya Surgical Optics, Inc.2023-05-04
Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear, ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni (P990018/S009)Menicon Co, Ltd.2023-05-01
Hydrus® Microstent (P170034/S009)Alcon Research, LLC2023-04-26
Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta (P220007)Alcon Laboratories, Inc.2023-04-25
MiSight 1 day (omafilcon A) (P180035/S017)CooperVision, Inc.2023-04-24
Silikon 1000 (P950008/S018)Alcon2023-04-20
TECNIS® 1-Piece IOL with TECNIS Simplicity™ Delivery System, TECNIS® OptiBlue™ 1-Piece IOL with TECNIS Simplicity™ Deliv (P980040/S158)Johnson & Johnson Surgical Vision, Inc.2023-04-20
VisuMax Femtosecond Laser (P150040/S013)Carl Zeiss Meditec, Inc.2023-04-13
Light Adjustable Lens (LAL), Light Delivery Device (LDD) System (P160055/S024)Rxsight, Inc.2023-03-31
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S060)Alcon Research, Ltd.2023-03-29
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (P840064/S079)Alcon Laboratories2023-03-29
MiSight 1 Day (omafilcon A) (P180035/S016)CooperVision, Inc.2023-03-22
VISTAKON (Senofilcon A) Brand Contact Lenses (P040045/S130)Vistakon, Division of Johnson & Johnson Vision Car2023-03-22
Hydrus® Microstent (P170034/S008)Alcon Research, LLC2023-03-14
Healon® PRO Sodium Hyaluronate Ophthalmic Viscoelastic Device, Healon Duet® PRO Dual Pack, Healon GV® PRO Sodium Hyaluro (P810031/S074)Johnson & Johnson Surgical Vision, Inc.2023-03-13
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S023)Alcon Laboratories, LLC2023-03-09
TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS Eyhance™ IOL, TECNIS Eyhan (P980040/S157)Johnson & Johnson Surgical Vision, Inc.2023-03-06
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S033)Rayner Intraocular Lenses , Ltd.2023-02-27
Silikon 1000 (P950008/S017)Alcon2023-02-22
StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) (P220009)Bausch Health Companies, Inc.2023-02-22
ClearView™ 3 (P200020/S003)Lenstec, Inc.2023-02-17
MEL 80 Excimer Laser System (P060004/S004)Carl Zeiss Meditec, Inc.2023-02-16
MEL 80 Excimer Laser System (P060004/S005)Carl Zeiss Meditec, Inc.2023-02-16
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