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Ophthalmic

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

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RecordFirmDate
TECNIS Simplicity Delivery System (P980040/S137)Johnson & Johnson Surgical Vision, Inc.2021-06-29
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S116)Vistakon, Division of Johnson & Johnson Vision Car2021-06-25
AcrySof™ IQ Vivity™ Extended Vision Intraocular Lens (IOL) (P930014/S136)Alcon Laboratories, Inc.2021-06-22
TECNIS Symfony Toric Extended Range of Vision IOLs (P980040/S136)Johnson & Johnson Surgical Vision, Inc.2021-06-16
C-flex lntraocular Lens, C-flex Aspheric Intraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric, RayOne Sph (P060011/S027)Rayner Intraocular Lenses , Ltd.2021-06-15
PreVue Pre-loaded System, IPURE Pre-loaded System (P080004/S041)Hoya Surgical Optics, Inc.2021-06-10
TECNIS Synergy™ IOL with TECNIS Simplicity® Delivery System, TECNIS Synergy™ Toric II IOL with TECNIS Simplicity® Delive (P980040/S135)Johnson & Johnson Surgical Vision, Inc.2021-06-07
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S129)CooperVision, Inc.2021-06-04
Hydrus Microsent (P170034/S005)Alcon Research, LLC2021-06-04
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S121)Vistakon, Division of Johnson & Johnson Vision Car2021-06-04
Ethos AquaTech Monthly, Ethos AquaTech Monthly for Astigmatism, Ethos AquaTech Monthly Multifocal (P080011/S120)CooperVision, Inc.2021-06-03
Ophthalmic (P000046/S028)Anika Therapeutics, Inc.2021-06-02
iSert Preloaded System (P080004/S031)Hoya Surgical Optics, Inc.2021-05-21
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S128)CooperVision, Inc.2021-05-20
Zeiss 3-piece Hydrophobic Acrylic Intraocular lens (IOL) (P100016/S007)Carl Zeiss Meditec Production, LLC2021-05-13
iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System (P080004/S040)Hoya Surgical Optics, Inc.2021-05-07
ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overnight Therapeutic Lenses for Myopia Management (P990018/S006)Menicon Co, Ltd.2021-05-06
Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S127)CooperVision, Inc.2021-05-06
Akreos Posterior Chamber Intraocular Lens (P060022/S026)Bausch & Lomb, Inc.2021-05-04
TECNIS Simplicity Delivery System (P980040/S134)Johnson & Johnson Surgical Vision, Inc.2021-05-04
TECNIS Synergy Intraocular Lens, TECNIS Synergy Toric II Intraocular Lens, TECNIS Synergy IOL with TECNIS Simplicity Del (P980040/S124)Johnson & Johnson Surgical Vision, Inc.2021-04-28
C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, RayOne Aspheric (P060011/S026)Rayner Intraocular Lenses , Ltd.2021-04-27
Clareon Aspheric Hydrophobic lOL; Clareon PanOptix Hydrophobic lOL; and Clareon Toric Aspheric Hydrophobic lOL (P190018/S010)Alcon Laboratories, LLC2021-04-23
Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints (P870024/S058)CooperVision, Inc.2021-04-23
AcrySof Multifocal Intraocular Lenses (P040020/S098)Alcon Research, Ltd.2021-04-22
Clareon Intraocular Lenses with the AutonoMe Delivery System (P190018/S011)Alcon Laboratories, LLC2021-04-22
Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S126)CooperVision, Inc.2021-04-22
AcrySof Intraocular Lenses (P930014/S135)Alcon Laboratories, Inc.2021-04-22
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S015)Rxsight, Inc.2021-04-20
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S125)CooperVision, Inc.2021-04-15
Bausch + Lomb Ultra (samfilcon A) Contact Lenses Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S012)Bausch and Lomb, Inc.,2021-04-08
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S041)Bausch & Lomb, Inc.2021-04-07
Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (HydrophlHc) Contact Lenses for Extended Wear (P080011/S124)CooperVision, Inc.2021-04-06
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S019)Rxsight, Inc.2021-04-01
Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S017)Euclid Vision Corporation2021-03-30
RayOne EMV (Model RAO200E) (P060011/S025)Rayner Intraocular Lenses , Ltd.2021-03-26
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S007)CooperVision, Inc.2021-03-26
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S008)CooperVision, Inc.2021-03-26
TECNIS Symfony™ OptiBlue™ Extended Range of Vision (ERV) IOL (P980040/S132)Johnson & Johnson Surgical Vision, Inc.2021-03-23
ClearVisc Ophthalmic Viscosurgical Device (OVD) (P200025)Bausch Health2021-03-23
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S018)Rxsight, Inc.2021-03-19
RxSight Light Adjustable Lens and Light Delivery System (P160055/S014)Rxsight, Inc.2021-03-17
Clareon PanOptix Trifocal Hydrophobic IOL, Clareon PanOptix Trifocal UV Absorbing IOL, Clareon PanOptix Trifocal Hydroph (P190018/S009)Alcon Laboratories, LLC2021-03-15
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S017)Rxsight, Inc.2021-03-10
TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOLs (P980040/S131)Johnson & Johnson Surgical Vision, Inc.2021-03-08
iStent inject Trabecular Micro-Bypass System (P170043/S008)Glaukos Corporation2021-03-03
PROVISC Ophthalmic Viscosurgical Device (P890047/S057)Alcon Research, Ltd.2021-03-03
VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT) (P840064/S074)Alcon Laboratories2021-03-03
Biofinity (comfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear (P080011/S123)CooperVision, Inc.2021-03-02
ezSert Preloaded Delivery System (P080004/S036)Hoya Surgical Optics, Inc.2021-03-01
iDesign Advanced WaveScan Studio, STAR Excimer Laser System (P930016/S062)Amo Manufacturing USA, LLC2021-02-26
AF-1 Family of Intraocular Lens (IOL) (P080004/S033)Hoya Surgical Optics, Inc.2021-02-26
VisuMax Femtosecond Laser (P150040/S009)Carl Zeiss Meditec, Inc.2021-02-24
SENSAR 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS 1-Piece IOL with Smart LOAD Delivery Technology, TECNIS O (P980040/S130)Johnson & Johnson Surgical Vision, Inc.2021-02-22
VisuMax Femtosecond Laser (P150040/S008)Carl Zeiss Meditec, Inc.2021-02-19
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S016)Rxsight, Inc.2021-02-19
AcrySof ReSTOR Posterior Chamber Intraocular Lenses (P040020/S094)Alcon Research, Ltd.2021-02-18
WaveLlght EX500 Laser System (P020050/S037)Alcon Laboratories, Inc.2021-02-18
AcrySof Posterior Chamber Intraocular Lens (P930014/S132)Alcon Laboratories, Inc.2021-02-18
WaveLlght EX500 Laser System (P030008/S033)Alcon Laboratories, Inc.2021-02-18
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe (P190018/S005)Alcon Laboratories, LLC2021-02-18
Silikon 1000 (P950008/S015)Alcon2021-02-15
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S019)Euclid Vision Corporation2021-02-08
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S016)Euclid Vision Corporation2021-02-04
TECNIS Simplicity Delivery System (P980040/S129)Johnson & Johnson Surgical Vision, Inc.2021-01-26
Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S122)CooperVision, Inc.2021-01-15
OcuCoat OVD (P860047/S034)Bausch & Lomb, Inc.2021-01-13
iSert Preloaded IOL System (P080004/S039)Hoya Surgical Optics, Inc.2021-01-13
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S039)Bausch & Lomb, Inc.2021-01-13
Biofinity XR Toric (Comfilcon A) soft (Hydrophilic) contact lenses for extended wear (P080011/S121)CooperVision, Inc.2021-01-12
TECNIS OptiBlue 1-Piece IOL, TECNIS OptiBlue Monofocal 1-Piece with Smart LOAD Delivery Technology, TECNIS 1-Piece OptiB (P980040/S128)Johnson & Johnson Surgical Vision, Inc.2021-01-08
TECNIS Multifocal Foldable Posterior Chamber IOL (P080010/S020)Johnson & Johnson Surgical Vision, Inc.2021-01-08
TECNIS CL Foldable Silicone Posterior Chamber IOL (P880081/S046)Johnson & Johnson Surgical Vision, Inc.2021-01-08
iSert Preloaded IOL System (P080004/S038)Hoya Surgical Optics, Inc.2021-01-08
TECNIS Foldable Acrylic IOL (P990080/S055)Johnson & Johnson Surgical Vision, Inc.2021-01-08
SENSAR 3-Piece Monofocal IOLs with OptiEdge Design, SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS Multifocal 1-Piece IO (P980040/S127)Johnson & Johnson Surgical Vision, Inc.2021-01-08
Softec HD, Softec I, Softec HD PS, Softec HDO, and Softec HDM IOLs (P090022/S038)Lenstec, Inc.2021-01-07
Natural Eyes HydraWear™ XW Multifocal (P080011/S112)CooperVision, Inc.2021-01-07
Hydrus Microstent (P170034/S006)Alcon Research, LLC2021-01-07
LensCrafters Monthly, LensCrafters Monthly Modern Lifestyle, LensCrafters Monthly for Astigmatism, LensCrafters Monthly (P080011/S110)CooperVision, Inc.2021-01-05
enVista One-Piece Foldable Acrylic Intraocular Lens (IOL) (P910061/S026)Bausch & Lomb2021-01-04
TECNIS Eyhance IOL, TECNIS Eyhance IOL with SmartLOAD Delivery Technology, TECNIS Eyhance IOL with TECNIS Simplicity Del (P980040/S117)Johnson & Johnson Surgical Vision, Inc.2020-12-29
WaveLight Allegretto Wave Excimer Laser System (P020050/S036)Alcon Laboratories, Inc.2020-12-22
WaveLight Allegretto Wave Excimer Laser System (P030008/S032)Alcon Laboratories, Inc.2020-12-22
enVista One-Piece Foldable Acrylic Intraocular Lens (P910056/S044)Bausch & Lomb, Inc.2020-12-21
Akreos One-Piece Foldable Acrylic Intraocular Lens (P060022/S028)Bausch & Lomb, Inc.2020-12-21
Resure Sealant (P130004/S010)Ocular Therapeutix, Inc.2020-12-17
PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S030)Alcon Laboratories2020-12-17
PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S048)Alcon Laboratories2020-12-17
AcrySof Posterior Chamber Intraocular Lens (P930014/S134)Alcon Laboratories, Inc.2020-12-17
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S097)Alcon Research, Ltd.2020-12-17
Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S015)Euclid Vision Corporation2020-12-17
Healon PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack, Healon GV PRO Sodium Hya (P810031/S069)Johnson & Johnson Surgical Vision, Inc.2020-12-16
Lotrafilcon B soft Contact Lenses for daily and extended wear (P010019/S077)Alcon Laboratories, Inc.2020-12-14
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S113)Vistakon, Division of Johnson & Johnson Vision Car2020-12-10
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S046)The Cooper Companies2020-12-10
VISTAKON (senofilcon A) Multifocal and Multifocal Toric Contact Lenses (P040045/S118)Vistakon, Division of Johnson & Johnson Vision Car2020-12-03
Healon EndoCoat Ophthalmic Viscosurgical Device (3% Sodium Hyaluronate) (P110007/S013)Johnson & Johnson Surgical Vision, Inc.2020-12-02
Ophthalmic Viscoelastic Devices, Healon Duet Dual Pack and Healon Duet PRO Dual Pack (P810031/S068)Johnson & Johnson Surgical Vision, Inc.2020-12-02
Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon GV PRO (P810031/S066)Johnson & Johnson Surgical Vision, Inc.2020-11-25
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Every clearance here is in the API, with alerts when new ones post.