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Ophthalmic

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

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RecordFirmDate
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S095)Vistakon, Johnson & Johnson Vision Products, Inc.2017-10-20
Methafilcon A and Methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S075)CooperVision, Inc.2017-10-17
LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S053)Alcon Laboratories, Inc.2017-10-17
Tetrafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (N17679/S037)CooperVision, Inc.2017-10-17
Hoya AF-1 Case Lens Case Lens and ISert Pre-loaded IOL Injector Systems (P080004/S018)Hoya Surgical Optics, Inc.2017-10-13
AcrySof IQ ReStor Posterior Chamber Intraocular Lenses (P040020/S072)Alcon Research, Ltd.2017-10-04
AcrySf Posterior Chamber Single Piece Intraocular Lenses (P930014/S105)Alcon Laboratories, Inc.2017-10-04
TECNIS Symfony and Symfony Toric Intraocular Lenses (P980040/S083)Johnson & Johnson Surgical Vision, Inc.2017-09-26
Lotrafilcon A Soft Contact Lenses for Daily and Extended wear (P010019/S059)Alcon Laboratories, Inc.2017-09-25
Lotrafilcon A and B Soft Contact Lenses for Daily and Extended Wear (P010019/S058)Alcon Laboratories, Inc.2017-09-21
AcrySof IQ Tonic Lenses (P930014/S103)Alcon Laboratories, Inc.2017-09-21
AcrySof ReStor +2.5 D Multifocal Intraocular lens /Toric Intraocular Lens/3.0 D Multifocal Toric Intraocular Lenses/ Tor (P040020/S070)Alcon Research, Ltd.2017-09-21
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S079)Vistakon, Division of Johnson & Johnson Vision Car2017-09-15
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S082)Vistakon, Division of Johnson & Johnson Vision Car2017-09-13
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear (P040029/S005)Euclid Vision Corporation2017-09-05
AIR, OPTIX, AQUA, MULTIFOCAL (lotrafilcon B) Soft Contact Lenses for daily and extended wear (P010019/S056)Alcon Laboratories, Inc.2017-09-05
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S081)Vistakon, Division of Johnson & Johnson Vision Car2017-09-05
Vistakon (Etafilcon A) Brand contact lenses (N18033/S094)Vistakon, Johnson & Johnson Vision Products, Inc.2017-08-30
Vistakon (Senofilcon A) Brand contact lenses (P040045/S080)Vistakon, Division of Johnson & Johnson Vision Car2017-08-30
CyPass Micro-Stent (P150037/S006)Alcon Research, Ltd.2017-08-18
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S074)CooperVision, Inc.2017-08-14
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S078)Vistakon, Division of Johnson & Johnson Vision Car2017-08-11
SofLens (polymacon) Visibility Tinted Contact Lens (N16895/S100)Bausch & Lomb, Inc.2017-08-11
CT LUCIA 202 IOL and CT LUCIA 602 IOL (P100016/S004)Carl Zeiss Meditec Production, LLC2017-08-09
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S061)CooperVision, Inc.2017-08-07
Visian Implantable Collamer Lens for Myopia (P030016/S033)STAAR Surgical Company2017-08-04
Collamer UV Absorbing Posterior Chamber Intraocular Lens (P990013/S037)Starr Surgical Co.2017-08-04
Collamer UV Absorbing Posterior Chamber Three and One Piece Foldable Intraocular LEns (P990013/S036)Starr Surgical Co.2017-08-02
Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products (P810031/S062)Johnson & Johnson Surgical Vision, Inc.2017-07-20
Visian Implantable Collamer Lens for Myopia (P030016/S032)STAAR Surgical Company2017-07-20
KAMRA INLAY (P120023/S005)Corneagen2017-07-18
AcrySof® IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System (P930014/S102)Alcon Laboratories, Inc.2017-07-18
Star S4 IR Excimer Laser System (P930016/S051)Amo Manufacturing USA, LLC2017-07-14
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S077)Vistakon, Division of Johnson & Johnson Vision Car2017-07-12
Vistakon (etafilcon A) Brand Contact Lenses (N18033/S093)Vistakon, Johnson & Johnson Vision Products, Inc.2017-07-12
PMMA Posterior Chamber Intraocular Lenses (P840039/S062)Bausch & Lomb, Inc.2017-07-11
Air Optix Night & Day Aqua (P010019/S055)Alcon Laboratories, Inc.2017-06-30
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System (P930016/S048)Amo Manufacturing USA, LLC2017-06-30
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) (P810025/S037)Bausch & Lomb, Inc.2017-06-28
OcuCoat OVD (P860047/S032)Bausch & Lomb, Inc.2017-06-28
Star S4 IR Excimer Laser System (P930016/S052)Amo Manufacturing USA, LLC2017-06-23
Biofinity XR Toric (P080011/S060)CooperVision, Inc.2017-06-22
VISTAKON (senofilcon A) ACUVUE OASYS® Brand Contact Lenses. (P040045/S076)Vistakon, Division of Johnson & Johnson Vision Car2017-06-20
Senofilcon A Reactive Monomer Mix (RMM) Batches (P040045/S074)Vistakon, Division of Johnson & Johnson Vision Car2017-06-20
Visian Implantable Collamer Lens for Myopia (P030016/S031)STAAR Surgical Company2017-06-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S073)Vistakon, Division of Johnson & Johnson Vision Car2017-06-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S075)Vistakon, Division of Johnson & Johnson Vision Car2017-06-16
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S092)Vistakon, Johnson & Johnson Vision Products, Inc.2017-06-16
Collamer, UV-Absorbing Posterior Chamber Intraocular Lens (P990013/S035)Starr Surgical Co.2017-06-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S072)Vistakon, Division of Johnson & Johnson Vision Car2017-06-14
Biofinity Sphere and Biofinity XR Sphere ; Biofinity Toric and Biofinity XR Toric ; Biofinity Multifocal ; Biofinity Ene (P080011/S059)CooperVision, Inc.2017-06-09
EC-5000 EXCIMER LASER SYSTEM (P970053/S016)Nidek Co., Ltd.2017-06-08
Lenstec Softec HD aspheric posterior chamber intraocular lens (P090022/S034)Lenstec, Inc.2017-06-05
Sensar 1-Piece IOL, Tecnis 1-Piece IOL, Tecnis 1-Piece OptiBlue IOL, Preloaded Tecnis 1-Piece IOL, Preloaded Tecnis 1-Pi (P980040/S082)Johnson & Johnson Surgical Vision, Inc.2017-06-05
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S080)Johnson & Johnson Surgical Vision, Inc.2017-06-02
TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL, TECNIS Multifocal 1-Piece IOLs, TECNIS Toric 1-Piece IOLs, TECNIS Toric (P980040/S081)Johnson & Johnson Surgical Vision, Inc.2017-05-24
ENVISTA IOL (P910056/S024)Bausch & Lomb, Inc.2017-05-23
C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S011)Rayner Intraocular Lenses , Ltd.2017-05-18
Ophthalmic Viscosurgical Devices (P840064/S066)Alcon Laboratories2017-05-18
PROVISC OVD (P890047/S051)Alcon Research, Ltd.2017-05-18
KAMRA INLAY (P120023/S004)Corneagen2017-05-16
CyPass System (P150037/S005)Alcon Research, Ltd.2017-05-15
iWear oxygen and iWear oxygen astigmatism (P080011/S058)CooperVision, Inc.2017-05-05
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S070)Vistakon, Division of Johnson & Johnson Vision Car2017-05-04
Vistakon (etafilcon A) Brand Contact Lenses (N18033/S090)Vistakon, Johnson & Johnson Vision Products, Inc.2017-05-04
AcrySof® Single Piece Intraocular Lenses (P930014/S101)Alcon Laboratories, Inc.2017-05-03
AcrySof® IQ ReSTOR® Intraocular Lenses (P040020/S069)Alcon Research, Ltd.2017-05-03
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S091)Vistakon, Johnson & Johnson Vision Products, Inc.2017-05-02
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S071)Vistakon, Division of Johnson & Johnson Vision Car2017-05-02
AIR OPTIX plus HYDRAGLYDE Soft Contact Lenses for Daily and Extended Wear (P010019/S054)Alcon Laboratories, Inc.2017-04-21
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S089)Vistakon, Johnson & Johnson Vision Products, Inc.2017-04-19
VISTAKON (senofilcon) Brand Contact Lenses (P040045/S069)Vistakon, Division of Johnson & Johnson Vision Car2017-04-19
Aaris intraocular lens model EC-3 and EC-3 PAL (P100016/S003)Carl Zeiss Meditec Production, LLC2017-04-18
BIOFINITY (comfilcon A) Soft (Hydrophilic) Contact Lenses (P080011/S056)CooperVision, Inc.2017-04-17
CyPass Micro-Stent (P150037/S004)Alcon Research, Ltd.2017-04-12
Allegro Topolyzer Vario (P020050/S026)Alcon Laboratories, Inc.2017-04-11
Allegro Topolyzer Vario (P030008/S022)Alcon Laboratories, Inc.2017-04-11
Biofinity XR Toric (P080011/S057)CooperVision, Inc.2017-04-10
COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P990013/S034)Starr Surgical Co.2017-04-06
Raindrop Near Vision Inlay (P150034/S003)Rvo 2.0, Inc. (D.B.A. Optics Medical)2017-04-05
iDesign Advanced WaveScan Studio (P930016/S050)Amo Manufacturing USA, LLC2017-04-05
CLARISERT PRELOADED IOL SYSTEM (P080004/S016)Hoya Surgical Optics, Inc.2017-03-31
Ophthaalmic Viscoelastic (P000046/S026)Anika Therapeutics, Inc.2017-03-31
EUCLID SYSTEMS ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S004)Euclid Vision Corporation2017-03-27
TECNIS Toric 1-Piece IOL Model ZCT (P980040/S079)Johnson & Johnson Surgical Vision, Inc.2017-03-24
Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens (P980040/S078)Johnson & Johnson Surgical Vision, Inc.2017-03-23
ACRYSOF RESTOR +2.5 D MULTIFOCAL INTRAOCULAR LENS (P040020/S067)Alcon Research, Ltd.2017-03-21
VISCOAT, DISCOCISC Ophthalmic Viscosurgical Device (P840064/S065)Alcon Laboratories2017-03-15
CYPASS SYSTEM (P150037/S002)Alcon Research, Ltd.2017-03-15
PROVISC Ophthalmic Viscosurgical Devices (P890047/S050)Alcon Research, Ltd.2017-03-15
Lenstec Softec HD Posterior Chamber Intraocular Lens (P090022/S032)Lenstec, Inc.2017-03-15
Pearl Vision Monthly (confilcon A) Soft (Hydriohilic) Contact Lenses , Pearle Vision Monthly for Astigmatism (comfilcon (P080011/S049)CooperVision, Inc.2017-03-10
STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISION ICL) (P030016/S022)STAAR Surgical Company2017-03-08
ACRYSOF Posterior Chamber INTRAOCULAR LENSES (P930014/S094)Alcon Laboratories, Inc.2017-03-03
Multi-Piece Posterior Chamber IOL (P810032/S065)Alcon Laboratories2017-03-03
Single-Piece Posterior Chamber IOL (P840060/S042)Alcon Laboratories2017-03-03
ACRYSOF RESTOR POSTERIOR CHAMBER IOL (P040020/S064)Alcon Research, Ltd.2017-03-03
Single-Piece Anterior Chamber IOL (P880087/S024)Alcon Laboratories2017-03-03
TECNIS TORIC 1-PIECE INTRAOCULAR LENSES (IOLS) EXTENDED CYLINDER RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600 (P980040/S077)Johnson & Johnson Surgical Vision, Inc.2017-03-03
ACRYSOF ASPHERIC UV ABSORBING TORIC INTRAOCULAR LENSES (P930014/S099)Alcon Laboratories, Inc.2017-03-02
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