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Ophthalmic

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

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RecordFirmDate
Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Cont (P080011/S143)CooperVision, Inc.2022-04-27
Soflens 38 (polymacon) Visibility Tinted Contact Lenses (N16895/S104)Bausch & Lomb, Inc.2022-04-20
CT LUCIA Intraocular Lens (IOL) (P100016/S013)Carl Zeiss Meditec Production, LLC2022-04-20
Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Energys, Biofinity Multifoca (P080011/S140)CooperVision, Inc.2022-04-14
Trulign® Toric Posterior Chamber Intraocular Lens (IOL) (P030002/S039)Bausch & Lomb, Inc.2022-04-08
TECNIS IOLs (P980040/S146)Johnson & Johnson Surgical Vision, Inc.2022-03-30
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S142)Alcon Laboratories, Inc.2022-03-25
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S102)Alcon Research, Ltd.2022-03-25
EVO/EVO+VISIAN Implantable Collamer Lens (P030016/S035)STAAR Surgical Company2022-03-25
CT Lucia 602, CT Lucia 202, CT Lucia 611P (P100016/S012)Carl Zeiss Meditec Production, LLC2022-03-25
Bausch + Lomb PureVision® (balafilcon A) Visibility Tinted Soft Contact Lenses (P980006/S034)Bausch & Lomb, Inc.2022-03-21
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S016)Bausch and Lomb, Inc.,2022-03-21
SILSOFT (ELASTOFILCON A) CONTACT LENSES (P850068/S014)Bausch & Lomb, Inc.2022-03-18
SOFLENS 38(polymacon) Soft Contact Lens (N16895/S105)Bausch & Lomb, Inc.2022-03-15
PreVue Pre-Loaded System (P080004/S042)Hoya Surgical Optics, Inc.2022-02-28
iStent® Trabecular Micro-Bypass Stent System (P080030/S023)Glaukos Corporation2022-02-18
iStent inject® Trabecular Micro-Bypass System Model (P170043/S012)Glaukos Corporation2022-02-18
TECNIS® Toric II 1-Piece IOLs, TECNIS Symfony™ Toric II Extended Range of Vision IOLs, TECNIS® Multifocal Toric II IOLs, (P980040/S145)Johnson & Johnson Surgical Vision, Inc.2022-02-17
Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) (P810031/S070)Johnson & Johnson Surgical Vision, Inc.2022-02-16
Biofinity Energys (P080011/S138)CooperVision, Inc.2022-02-16
Clareon PanOptix Trifocal UV Absorbing Hydrophobic Intraocular Lens (IOL), Clareon PanOptix Toric Trifocal Hydrophobic I (P190018/S012)Alcon Laboratories, LLC2022-02-14
The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th (P980040/S144)Johnson & Johnson Surgical Vision, Inc.2022-02-14
ISPAN Perfluoropropane C3F8 Gas (P900066/S015)Airgas Therapeutics, LLC2022-02-02
Voyant Monthly, Voyant Monthly Premium, Voyant Monthly Toric, Voyant Monthly Multifocal (P080011/S131)CooperVision, Inc.2022-02-01
MiSight 1 Day (omafilcon A) (P180035/S009)CooperVision, Inc.2022-01-26
Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO (P190018/S013)Alcon Laboratories, LLC2022-01-26
Eureka!™ Monthly (samfilcon A) Contact Lenses (P170035/S014)Bausch and Lomb, Inc.,2022-01-24
enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S049)Bausch & Lomb, Inc.2022-01-19
Akreos® Posterior Chamber Intraocular Lens (IOL) (P060022/S029)Bausch & Lomb, Inc.2022-01-19
Crystalens Accommodating Posterior Chamber & Trulign Toric Intraocular Lenses (IOL) (P030002/S040)Bausch & Lomb, Inc.2022-01-19
Sofport® Advanced Optics Posterior Chamber Intraocular Lens (IOL) (P910061/S027)Bausch & Lomb2022-01-19
Bausch+ Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses (P170035/S015)Bausch and Lomb, Inc.,2022-01-13
Bausch+ Lomb Pure Vision® (balafilcon A) Visibility Tinted Soft Contact Lenses (P980006/S033)Bausch & Lomb, Inc.2022-01-13
AIR OPTIX NIGHT & DAY AQUA, AIR OPTIX AQUA, AIR OPTIX AQUA MULTIFOCAL, AIR OPTIX Plus HYDRAGLYDE, AIR OPTIX Plus HYDRAGL (P010019/S081)Alcon Laboratories, Inc.2022-01-12
Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S137)CooperVision, Inc.2022-01-06
Raindrop® Near Vision Inlay (P150034/S009)Rvo 2.0, Inc. (D.B.A. Optics Medical)2022-01-04
Pearle Vision Monthly Balance (P080011/S130)CooperVision, Inc.2022-01-04
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (P190018/S017)Alcon Laboratories, LLC2021-12-28
iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System (P080004/S043)Hoya Surgical Optics, Inc.2021-12-28
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S117)Vistakon, Division of Johnson & Johnson Vision Car2021-12-23
TECNIS Symfony™ OptiBlue® Extended Range of Vision (ERV) IOL with TECNIS Simplicity® Delivery System, Model DXR00V; TECN (P980040/S142)Johnson & Johnson Surgical Vision, Inc.2021-12-23
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S016)Alcon Laboratories, LLC2021-12-22
Ophthalin, Anikavisc, Nuvisc (P000046/S030)Anika Therapeutics, Inc.2021-12-22
Clareon Aspheric Hydrophobic Acrylic IOL, Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Preloaded Delivery (P190018/S015)Alcon Laboratories, LLC2021-12-21
AcrySof IQ Aspheric IOL with UltraSert (P930014/S140)Alcon Laboratories, Inc.2021-12-21
Biofinity Sphere, Biofinity Toric (P080011/S136)CooperVision, Inc.2021-12-10
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S123)Vistakon, Division of Johnson & Johnson Vision Car2021-12-08
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S076)Alcon Laboratories2021-12-03
DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S075)Alcon Laboratories2021-12-03
Single-Piece PMMA Anterior Chamber IOLs (P880087/S031)Alcon Laboratories2021-12-02
Single-Piece PMMA Posterior Chamber IOL (P840060/S049)Alcon Laboratories2021-12-02
ADATO Sil-Ol 5000 Silicone Oil (P910071/S018)Bausch & Lomb2021-12-02
TECNIS Symfony Toric II OptiBlue Extended Range of Vision (ERV) IOL (P980040/S140)Johnson & Johnson Surgical Vision, Inc.2021-12-01
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S014)Alcon Laboratories, LLC2021-12-01
Hydrus® Microstent (P170034/S007)Alcon Research, LLC2021-11-30
Perfluoron (P950018/S020)Alcon Laboratories2021-11-23
WaveLight EX500 Laser System (P020050/S039)Alcon Laboratories, Inc.2021-11-19
Biofinity XR Toric; Biofinity Toric Multifocal (P080011/S134)CooperVision, Inc.2021-11-19
WaveLight EX500 Laser System (P030008/S035)Alcon Laboratories, Inc.2021-11-19
PureVision2 (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S031)Bausch & Lomb, Inc.2021-11-18
Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S133)CooperVision, Inc.2021-11-17
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dua (P810031/S071)Johnson & Johnson Surgical Vision, Inc.2021-11-17
TECNIS Symfony OptiBlue Extended Range of Vision (ERV) IOL, TECNIS Symfony Toric II OptiBlue Extended Range of Vision (E (P980040/S139)Johnson & Johnson Surgical Vision, Inc.2021-11-15
Biofinity XR Toric; Biofinity Toric Multifocal (P080011/S132)CooperVision, Inc.2021-11-08
ReSure Sealant (P130004/S011)Ocular Therapeutix, Inc.2021-11-02
Nuvisc, Anikavisc, Ophthalin (P000046/S029)Anika Therapeutics, Inc.2021-10-21
enVista® hydrophobic acrylic intraocular lens (IOL) (P910056/S048)Bausch & Lomb, Inc.2021-10-14
Light Adjustable Lens, Light Delivery Device (P160055/S021)Rxsight, Inc.2021-10-05
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S101)Alcon Research, Ltd.2021-10-01
Softec HD, Sotlec I, Softec HD PS, Softec HDO, Softec HDM (P090022/S039)Lenstec, Inc.2021-09-28
Lotralcon B soft contact lenses (P010019/S080)Alcon Laboratories, Inc.2021-09-28
ISPAN PERFLUOROPROPANE C3F8 GAS (P900066/S013)Airgas Therapeutics, LLC2021-09-28
Lotrafilcon A and B soft contact lenses (P010019/S079)Alcon Laboratories, Inc.2021-09-10
iStent inject W Trabecular Micro-Bypass System (P170043/S010)Glaukos Corporation2021-09-10
TECNIS Simplicity Delivery System; SmartLOAD Delivery Technology (P980040/S133)Johnson & Johnson Surgical Vision, Inc.2021-09-10
iStent inject W Trabecular Micro-Bypass System (P170043/S009)Glaukos Corporation2021-08-31
Amvisc Ophthalmic Viscosurgical Device, Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S043)Bausch & Lomb, Inc.2021-08-27
PureVision (balafilcon A) Contact Lens (P980006/S032)Bausch & Lomb, Inc.2021-08-27
Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear (P010019/S078)Alcon Laboratories, Inc.2021-08-27
Ultra (samfilcon A) Contact Lens (P170035/S013)Bausch and Lomb, Inc.,2021-08-27
VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S122)Vistakon, Division of Johnson & Johnson Vision Car2021-08-23
AcrySof® Posterior Chamber Intraocular Lens (P930014/S139)Alcon Laboratories, Inc.2021-08-23
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S028)Rayner Intraocular Lenses , Ltd.2021-08-03
TECNIS Family of 1-piece IOLs packaged in the Daisy Wheel Configuration (P980040/S141)Johnson & Johnson Surgical Vision, Inc.2021-07-28
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S003)CooperVision, Inc.2021-07-26
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S020)Euclid Vision Corporation2021-07-26
enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S046)Bausch & Lomb, Inc.2021-07-21
Collamer Intraocular Lens (CIOL) (P990013/S041)Starr Surgical Co.2021-07-19
Visian Implantable Collamer Lens (ICL) (P030016/S041)STAAR Surgical Company2021-07-19
AcrySof Posterior Chamber Intraocular Lens (P930014/S137)Alcon Laboratories, Inc.2021-07-14
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S099)Alcon Research, Ltd.2021-07-14
Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual (P810031/S072)Johnson & Johnson Surgical Vision, Inc.2021-07-13
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S004)CooperVision, Inc.2021-07-12
WaveLight EX500 Laser System (P030008/S034)Alcon Laboratories, Inc.2021-07-08
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S042)Bausch & Lomb, Inc.2021-07-08
CT LUCIA Intraocular lens (Model 611P) (P100016/S008)Carl Zeiss Meditec Production, LLC2021-07-08
WaveLight EX500 Laser System (P020050/S038)Alcon Laboratories, Inc.2021-07-08
AcrySof Intraocular Lenses (P930014/S131)Alcon Laboratories, Inc.2021-07-01
AcrySof IQ ReSTOR Intraocular Lenses (P040020/S093)Alcon Research, Ltd.2021-07-01
TECNIS Synergy IOL with TECNIS Simplicity Delivery System, TECNIS Synergy Toric II IOL with TECNIS Simplicity Delivery S (P980040/S138)Johnson & Johnson Surgical Vision, Inc.2021-06-29
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