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Ophthalmic

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

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RecordFirmDate
CyPass Micro-Stent (P150037/S009)Alcon Research, Ltd.2018-05-30
CustomFlex Artificial Iris (P170039)Humanoptics AG2018-05-30
iStent Trabecular Micro-Bypass Stent System (P080030/S021)Glaukos Corporation2018-05-29
CyPass System 241-S (P150037/S007)Alcon Research, Ltd.2018-05-29
VISTAKON (etafilcon A) ACUVUE 2 Brand Contact Lenses (N18033/S098)Vistakon, Johnson & Johnson Vision Products, Inc.2018-05-24
Lotrafilcon A Soft Contact Lenses for Extended Wear (P010019/S065)Alcon Laboratories, Inc.2018-05-22
WaveLight EX500 Laser System (P020050/S029)Alcon Laboratories, Inc.2018-05-11
WaveNet Planning Software (P030008/S025)Alcon Laboratories, Inc.2018-05-11
Tecnis 3-piece Acrylic Monofocal (P990080/S046)Johnson & Johnson Surgical Vision, Inc.2018-05-09
Tecnis 3-piece Multifocal (P080010/S015)Johnson & Johnson Surgical Vision, Inc.2018-05-09
Tecnis CL (P880081/S041)Johnson & Johnson Surgical Vision, Inc.2018-05-09
Sensar 1-piece IOL, Tecnis 1-piece IOL, Tecnis 1-piece Optiblue IOL, Preloaded Tecnis 1-piece IOL, Preloaded Tecnis 1-pi (P980040/S088)Johnson & Johnson Surgical Vision, Inc.2018-05-09
Vistakon (Senofilcon A) Brand Contact Lenses (P040045/S097)Vistakon, Division of Johnson & Johnson Vision Car2018-05-04
VisuMax Femtosecond Laser System (P150040/S002)Carl Zeiss Meditec, Inc.2018-05-02
Bausch + Lomb Ultra (samfilcon A) Contact Lenses (P170035)Bausch and Lomb, Inc.,2018-04-30
Acrysof IQ Aspheric UV absorbing IOL with the UltraSert Pre-Loaded Delivery System (P930014/S110)Alcon Laboratories, Inc.2018-04-26
Hoya iSert, Clarisert Intraocular Lens (P080004/S022)Hoya Surgical Optics, Inc.2018-04-25
Sofmed brethables XW, Sofmed breathables XW premium, Sofmed breathables XW toric, Sofmed breathables XW multifocal (P080011/S068)CooperVision, Inc.2018-04-25
VISCOAT Opthalmic Viscoelastic System, DUOVISC Opthalmic Viscoelastic System (P840064/S068)Alcon Laboratories2018-04-24
PROVISC Opthalmic Viscoelastic Device (P890047/S053)Alcon Research, Ltd.2018-04-24
TECNIS Toric1-Piece Intraocular Lenses (IOLs) Models ZCT300 and ZCT400 (P980040/S086)Johnson & Johnson Surgical Vision, Inc.2018-04-23
BIOLON (P960011/S030)Altacor , Ltd.2018-04-23
Air Optix Aqua, Air Optix Plus HydraGlyde Soft Contact Lenses (P010019/S064)Alcon Laboratories, Inc.2018-04-19
Sensar IOL, Tecnis Toric, Tecnis Symfony, Tecnis Symfony Toric (P980040/S087)Johnson & Johnson Surgical Vision, Inc.2018-04-17
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S078)Alcon Research, Ltd.2018-04-11
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S111)Alcon Laboratories, Inc.2018-04-11
Natural Eyes Hydra Wear XW and Natural Eyes XW for Astigmatism (P080011/S066)CooperVision, Inc.2018-04-10
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S073)CooperVision, Inc.2018-04-10
Bausch & Lomb PureVision (balafilcon A) Contact Lenses (P980006/S027)Bausch & Lomb, Inc.2018-04-10
AquaClear Premium (P080011/S067)CooperVision, Inc.2018-04-09
Wave Light EX500 Laser (P020050/S028)Alcon Laboratories, Inc.2018-04-09
Wave Light EX500 Laser (P030008/S024)Alcon Laboratories, Inc.2018-04-09
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S096)Vistakon, Division of Johnson & Johnson Vision Car2018-04-03
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S072)CooperVision, Inc.2018-03-29
PureVision (balafilcon A) Visibility Tinted Contact Lens (P980006/S026)Bausch & Lomb, Inc.2018-03-29
Raindrop Near Vision Inlay (P150034/S005)Rvo 2.0, Inc. (D.B.A. Optics Medical)2018-03-27
BVI 1% OVD (formerly BD 1% OVD and Biolon) (P960011/S029)Altacor , Ltd.2018-03-15
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S095)Vistakon, Division of Johnson & Johnson Vision Car2018-03-14
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S097)Vistakon, Johnson & Johnson Vision Products, Inc.2018-03-14
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S078)CooperVision, Inc.2018-03-14
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S071)CooperVision, Inc.2018-03-14
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S094)Vistakon, Division of Johnson & Johnson Vision Car2018-03-14
Lens Optic body diameter cut (P100016/S005)Carl Zeiss Meditec Production, LLC2018-03-06
Lotrafilcon A Soft Contact Lenses for Extended Wear (P010019/S063)Alcon Laboratories, Inc.2018-03-02
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon (P810031/S064)Johnson & Johnson Surgical Vision, Inc.2018-02-27
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S070)CooperVision, Inc.2018-02-26
Raindrop Near Vision Inlay (P150034/S007)Rvo 2.0, Inc. (D.B.A. Optics Medical)2018-02-15
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S092)Vistakon, Division of Johnson & Johnson Vision Car2018-02-13
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S093)Vistakon, Division of Johnson & Johnson Vision Car2018-02-09
STAR Excimer Laser System (P930016/S054)Amo Manufacturing USA, LLC2018-02-09
AIR OPTIX plus HydraGlyde / AIR OPTIX plus HydraGlyde for Astigmatism / AIR OPTIX plus HydraGlyde Multifocal / AIR OPTIX (P010019/S062)Alcon Laboratories, Inc.2018-02-06
Glaukos iStent Trabecular Micro-Bypass Stent System (P080030/S020)Glaukos Corporation2018-02-06
Hoya iSert and Clarisert Intraocular Lens (P080004/S021)Hoya Surgical Optics, Inc.2018-02-01
Sodium Hyaluronate Ophtalmic Viscoelastc Devices (OVD); Healon PRO, Healon5 PRO, and Healon DUet PRO Dual Pack (P810031/S063)Johnson & Johnson Surgical Vision, Inc.2018-01-26
ReVision Optics Raindrop Near Vision Inlay (P150034/S002)Rvo 2.0, Inc. (D.B.A. Optics Medical)2018-01-24
AcrySof® Single Piece Intraocular Lenses (P930014/S104)Alcon Laboratories, Inc.2018-01-23
AcrySof® IQ ReSTOR® Intraocular Lenses (P040020/S071)Alcon Research, Ltd.2018-01-23
Nidek EC-5000 Excimer Laser System (P970053/S017)Nidek Co., Ltd.2018-01-12
Raindrop Near Vision Inlay (P150034/S006)Rvo 2.0, Inc. (D.B.A. Optics Medical)2018-01-12
enVista One Piece Hydrophobic Acrylic Intraocular Lens Vial Manufacturing (P910056/S029)Bausch & Lomb, Inc.2018-01-11
AcrySof Aspheric UV Absorbing ReSTOR Toric IOL +2.5 and +3.0 (P040020/S073)Alcon Research, Ltd.2018-01-10
AcrySof Intraocular Lenses (P930014/S109)Alcon Laboratories, Inc.2018-01-08
AcrySof ReSTOR Intraocular Lenses (P040020/S077)Alcon Research, Ltd.2018-01-08
BVI 1%OVD (fonnerly BD 1%OVD and Biolon) (P960011/S028)Altacor , Ltd.2018-01-04
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) (P960011/S027)Altacor , Ltd.2018-01-02
Comfilcon A Soft (Hydrophilic) Extended Wear Contace Lenses (P080011/S065)CooperVision, Inc.2017-12-28
WaveLight EX500 Laser System (P020050/S027)Alcon Laboratories, Inc.2017-12-21
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S107)Alcon Laboratories, Inc.2017-12-21
AcrySof IQ ReSTOR Posterior Chambers Intraocular Lenses (P040020/S075)Alcon Research, Ltd.2017-12-21
WaveLight EX500 Laser System (P030008/S023)Alcon Laboratories, Inc.2017-12-21
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S091)Vistakon, Division of Johnson & Johnson Vision Car2017-12-19
Clarisert Preloaded IOL System (P080004/S020)Hoya Surgical Optics, Inc.2017-12-19
ocufilcon D Sift (Hydrophilie) Contact Lenses (P890023/S028)The Cooper Companies2017-12-19
AcrySof Posterior Chamber Single Piece Intraocular Lenses (P930014/S108)Alcon Laboratories, Inc.2017-12-18
CyPass Ultra System (P150037/S008)Alcon Research, Ltd.2017-12-18
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S076)Alcon Research, Ltd.2017-12-18
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S090)Vistakon, Division of Johnson & Johnson Vision Car2017-12-14
Comflicon A Soft (Hydrophilic ) Extended Wear Contact Lenses (P080011/S064)CooperVision, Inc.2017-12-12
TECNIS Symfony 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, and TECNIS Multifocal 1-Piece IOL (P980040/S085)Johnson & Johnson Surgical Vision, Inc.2017-12-12
Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses (P060011/S013)Rayner Intraocular Lenses , Ltd.2017-12-07
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S089)Vistakon, Division of Johnson & Johnson Vision Car2017-12-06
EnVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL), Model MX60E Lens Holder (P910056/S028)Bausch & Lomb, Inc.2017-12-04
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S088)Vistakon, Division of Johnson & Johnson Vision Car2017-12-01
AcrySof IQ ReSTOR Intraocular Lenses (P040020/S074)Alcon Research, Ltd.2017-11-30
AcrySof Single Piece Intraocular Lenses (P930014/S106)Alcon Laboratories, Inc.2017-11-30
Ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S029)The Cooper Companies2017-11-22
LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD) (P160055)Rxsight, Inc.2017-11-22
Frequency Xcel Toric (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses. / Frequency Xcel Toric XR (methaf (P850079/S076)CooperVision, Inc.2017-11-22
Biofinity XR Toric (comfilcon A ) Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S063)CooperVision, Inc.2017-11-22
Polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S058)CooperVision, Inc.2017-11-22
Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses (N17679/S038)CooperVision, Inc.2017-11-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S086)Vistakon, Division of Johnson & Johnson Vision Car2017-11-15
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S096)Vistakon, Johnson & Johnson Vision Products, Inc.2017-11-15
AIR OPTIX plus HydraGlyde (lotrafilcon B) Soft Contact Lenses for Daily and Extedned Wear (P010019/S061)Alcon Laboratories, Inc.2017-11-13
Biofinity Toric (P080011/S062)CooperVision, Inc.2017-11-13
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S087)Vistakon, Division of Johnson & Johnson Vision Car2017-11-08
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S085)Vistakon, Division of Johnson & Johnson Vision Car2017-11-06
Provisc Ophthalmic Viscosurgical Devices (P890047/S052)Alcon Research, Ltd.2017-11-01
Duovisc, Viscoat, Discovisc Ophthalmic Viscosurgical Devices (P840064/S067)Alcon Laboratories2017-11-01
enVista Hydrophobic Acrylic Intraocular Lens (P910056/S026)Bausch & Lomb, Inc.2017-11-01
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