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Ophthalmic

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

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RecordFirmDate
Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S008)Alcon Laboratories, LLC2020-11-24
VISTAKON (senofilcon A) ACUVUE OASYS Brand Contact Lenses for ASTIGMATISM with HYDRACLEAR Plus (P040045/S119)Vistakon, Division of Johnson & Johnson Vision Car2020-11-23
VisuMax Femtosecond Laser (P150040/S007)Carl Zeiss Meditec, Inc.2020-11-23
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S011)Bausch and Lomb, Inc.,2020-11-19
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S108)Vistakon, Johnson & Johnson Vision Products, Inc.2020-11-19
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S120)Vistakon, Division of Johnson & Johnson Vision Car2020-11-19
Biofinity (comfilcon A) XR Toric and Toric Multifocal Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S119)CooperVision, Inc.2020-11-17
SENSAR 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1- (P980040/S126)Johnson & Johnson Surgical Vision, Inc.2020-11-12
TECNIS Foldable Acrylic IOL (P990080/S054)Johnson & Johnson Surgical Vision, Inc.2020-11-12
Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S007)Alcon Laboratories, LLC2020-11-12
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S118)CooperVision, Inc.2020-11-05
TECNIS 1-Piece IOL with TECNIS Simplicity Delivery System, TECNIS OptiBlue 1-Piece IOL with TECNIS Simplicity Delivery S (P980040/S118)Johnson & Johnson Surgical Vision, Inc.2020-11-04
TECNIS Symfony Toric II OptiBlue Extended Range of Vision Intraocular Lenses (P980040/S123)Johnson & Johnson Surgical Vision, Inc.2020-11-03
PreVue Preloaded IOL System (P080004/S035)Hoya Surgical Optics, Inc.2020-11-03
SimplifEYE Preloaded Delivery System for enVista Intraocular Lens (P910056/S042)Bausch & Lomb, Inc.2020-10-28
TECNIS Multifocal Toric II Intraocular Lenses (P980040/S120)Johnson & Johnson Surgical Vision, Inc.2020-10-26
PROVISC Ophthalmic Viscosurgical Device (P890047/S056)Alcon Research, Ltd.2020-10-23
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), and DI (P840064/S073)Alcon Laboratories2020-10-23
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S037)Lenstec, Inc.2020-10-23
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S010)Bausch and Lomb, Inc.,2020-10-19
C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric (P060011/S023)Rayner Intraocular Lenses , Ltd.2020-10-16
Biomedics Toric (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S047)The Cooper Companies2020-10-16
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S036)Lenstec, Inc.2020-10-15
TECNIS Toric 1-Piece Intraocular Lense (IOLs) (P980040/S115)Johnson & Johnson Surgical Vision, Inc.2020-10-14
iSert Preloaded, Clarisert and IPURE AF-1 Intraocular Lenses (P080004/S037)Hoya Surgical Optics, Inc.2020-10-13
VisuMax Femtosecond Laser (P150040/S006)Carl Zeiss Meditec, Inc.2020-10-07
Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S117)CooperVision, Inc.2020-10-05
AcrySof Posterior Chamber Intraocular Lens (P930014/S133)Alcon Laboratories, Inc.2020-10-02
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S096)Alcon Research, Ltd.2020-10-02
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S040)Bausch & Lomb, Inc.2020-10-01
Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S106)CooperVision, Inc.2020-10-01
Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric (P190018/S006)Alcon Laboratories, LLC2020-09-29
Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S030)Bausch & Lomb, Inc.2020-09-28
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S009)Bausch and Lomb, Inc.,2020-09-28
One-Piece IOLs with Daisy-Wheel packaging configuration, One-Piece IOLs with TENIC iTEC Preloaded Delivery System, One-P (P980040/S121)Johnson & Johnson Surgical Vision, Inc.2020-09-23
TECNIS iTEC Preloaded Delivery System, TECNIS Simplicity Delivery System (P980040/S122)Johnson & Johnson Surgical Vision, Inc.2020-09-23
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses Extended Wear (P890023/S045)The Cooper Companies2020-09-22
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S116)CooperVision, Inc.2020-09-21
VISCOAT Ophthalmic Viscoelastic System and DUOVISC Ophthalmic Viscoelastic System (P840064/S072)Alcon Laboratories2020-09-16
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S115)CooperVision, Inc.2020-09-16
PROVISC Ophthalmic Viscosurgical Device (P890047/S055)Alcon Research, Ltd.2020-09-16
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S044)The Cooper Companies2020-09-16
Biofinity Energys (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S114)CooperVision, Inc.2020-09-04
CustomFlex ArtificialIris (P170039/S003)Humanoptics AG2020-09-04
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S043)The Cooper Companies2020-09-01
Hydrasoft (methafilcon B) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S089)CooperVision, Inc.2020-09-01
Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S057)CooperVision, Inc.2020-08-31
Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints (P050031/S007)CooperVision, Inc.2020-08-31
Paragon Z CRT and Paragon Z CRT Dual Axis Rigid Gas Permeable Contact Lenses in Clear and Tints (P050031/S006)CooperVision, Inc.2020-08-31
Paragon CRT, Paragon CRT 100, Paragon CRT Dual Axis, and Paragon RG-4 Rigid Gas Permeable Contact Lenses in Clear and Ti (P870024/S056)CooperVision, Inc.2020-08-31
AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOLs (P040020/S095)Alcon Research, Ltd.2020-08-28
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S113)CooperVision, Inc.2020-08-27
TECNIS Toric II 1-Piece IOLs, TECNIS Symfony Toric II Extended Range of Vision IOLs (P980040/S113)Johnson & Johnson Surgical Vision, Inc.2020-08-27
Euclid Systems Orthokeratology (oprifocon A) or (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S014)Euclid Vision Corporation2020-08-24
WaveLight EX500 Laser (P020050/S035)Alcon Laboratories, Inc.2020-08-21
WaveLight EX500 Laser (P030008/S031)Alcon Laboratories, Inc.2020-08-21
Paragon HDS® (paflufocon B), FluoroPerm® 151 (paflufocon D), Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contac (P870024/S055)CooperVision, Inc.2020-08-18
Paragon HDS 100 and Fluoroperm 151 (paflufocon D) Rigid Gas Permeable Contact Lens in Clear and Tints (P870024/S054)CooperVision, Inc.2020-08-13
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S109)CooperVision, Inc.2020-08-11
Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S111)CooperVision, Inc.2020-08-11
RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S010)Rxsight, Inc.2020-08-07
One-Piece IOLs with Daisy-Wheel packaging configuration, TENIC iTEC Preloaded Delivery System, TECNIS SmartLOAD Delivery (P980040/S119)Johnson & Johnson Surgical Vision, Inc.2020-08-03
Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S088)CooperVision, Inc.2020-07-28
Biofinity (comfilcon A) soft (hydrophilic) contact lenses for extended wear (P080011/S108)CooperVision, Inc.2020-07-28
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S107)CooperVision, Inc.2020-07-28
PERFLUORON (P950018/S019)Alcon Laboratories2020-07-24
Clareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi (P190018/S003)Alcon Laboratories, LLC2020-07-20
Clareon PanOptix Trifocal Hydrophobic IOL, and Clareon PanOptix Trifocal Hydrophobic IOL with the AutonoMe Automated Pre (P190018/S002)Alcon Laboratories, LLC2020-07-20
ReSure Sealant (P130004/S009)Ocular Therapeutix, Inc.2020-07-16
Clareon and Clareon Toric Intraocular Lenses (IOLs) (P190018/S001)Alcon Laboratories, LLC2020-07-15
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S008)Bausch and Lomb, Inc.,2020-07-14
iStent inject W Trabecular Micro-Bypass System (P170043/S005)Glaukos Corporation2020-07-02
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S006)CooperVision, Inc.2020-06-25
C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric Intraocular Lens, and RayOneAspheric the lens (P060011/S024)Rayner Intraocular Lenses , Ltd.2020-06-24
Clareon lntraocular Lenses with the AutonoMe Delivery System (P190018/S004)Alcon Laboratories, LLC2020-06-16
VISTAKON (Senofilcon A) Brand Contact Lenses (P040045/S115)Vistakon, Division of Johnson & Johnson Vision Car2020-06-16
iSert Preloaded Posterior Chamber One-Piece Intraocular Lens (IOL) (P080004/S034)Hoya Surgical Optics, Inc.2020-06-15
TECNIS Toric 1-Piece Intraocular Lenses (IOL) (P980040/S111)Johnson & Johnson Surgical Vision, Inc.2020-06-11
Rayner C-flex, C-flex Aspheric, Aspheric Intracular lenses and RayOne Aspheric (P060011/S022)Rayner Intraocular Lenses , Ltd.2020-06-10
iStent inject Trabecular Micro-Bypass System (P170043/S003)Glaukos Corporation2020-06-01
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S107)Vistakon, Johnson & Johnson Vision Products, Inc.2020-06-01
VISTAKON (senofilcon A)Brand Contact Lenses (P040045/S114)Vistakon, Division of Johnson & Johnson Vision Car2020-06-01
TECNIS Symfony OptiBlue IOL, TECNIS Symfomy Toric II OptiBlue IOLs (P980040/S112)Johnson & Johnson Surgical Vision, Inc.2020-05-28
C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric (P060011/S021)Rayner Intraocular Lenses , Ltd.2020-05-26
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S009)Rxsight, Inc.2020-05-22
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S011)Rxsight, Inc.2020-05-21
enVista One-Piece Hydrophobic Acrylic Toric Intraoculer Lens (IOL) (P910056/S043)Bausch & Lomb, Inc.2020-05-19
Healon EndoCoat Ophtalmic Viscosurgical Devices (OVD) (3% Sodium Hyaluronate) (P110007/S012)Johnson & Johnson Surgical Vision, Inc.2020-05-11
Sodium Hyaluronate Ophtalmic Viscoelastic Devices (OVD), Healon Duet Dual Pack and Healon Duet PRO Dual Pack (P810031/S067)Johnson & Johnson Surgical Vision, Inc.2020-05-11
ReSure Sealant (P130004/S008)Ocular Therapeutix, Inc.2020-05-05
AcrySof (R) Intraocular Lenses (P930014/S130)Alcon Laboratories, Inc.2020-05-05
TECNIS Symfony PLUS Extended Range of Vision Intraocular Lens (IOL), Model ZHR00, TECNIS Symfony PLUS Extended Range of (P980040/S109)Johnson & Johnson Surgical Vision, Inc.2020-05-01
iStent inject Trabecular Micro-Bypass System (P170043/S007)Glaukos Corporation2020-04-30
iStent inject Trabecular Micro-Bypass System (P170043/S006)Glaukos Corporation2020-04-30
AcrySof Intraocular Lenses and Delivery System (P930014/S129)Alcon Laboratories, Inc.2020-04-23
IPure Preloaded IOL System (P080004/S028)Hoya Surgical Optics, Inc.2020-04-23
Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S053)CooperVision, Inc.2020-04-20
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S105)CooperVision, Inc.2020-04-20
Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S087)CooperVision, Inc.2020-04-20
IPure Preloaded IOL System (P080004/S030)Hoya Surgical Optics, Inc.2020-04-17
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