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Ophthalmic

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

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RecordFirmDate
Light Adjustable Lens, Light Delivery Device (P160055/S039)Rxsight, Inc.2024-09-03
Hydrus® Microstent (P170034/S011)Alcon Research, LLC2024-08-28
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012)Alcon Research, LLC2024-08-26
Comfilcon A Soft (Hydrophilic) contact lenses for extended wear (P080011/S170)CooperVision, Inc.2024-08-20
MiSight 1 Day (omafilcon A) (P180035/S023)CooperVision, Inc.2024-08-20
PROVSIC™ Ophthalmic Viscosurgical Device (P890047/S065)Alcon Research, Ltd.2024-08-12
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S110)Alcon Research, Ltd.2024-08-09
iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System (P930016/S067)Amo Manufacturing USA, LLC2024-08-09
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S151)Alcon Laboratories, Inc.2024-08-09
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S037)Alcon Laboratories, LLC2024-08-09
enVista® hydrophobic acrylic IOL, enVista® toric hydrophobic aryclic IOL, enVista® Aspire™ hydrophobic acrylic IOL, enVi (P910056/S056)Bausch & Lomb, Inc.2024-08-07
Capsular Tension Ring (CTR) and RingJect (P030023/S009)Ophtec BV2024-08-01
MiSight 1 Day (omafilcon A) (P180035/S022)CooperVision, Inc.2024-08-01
Biofinity Sphere (comfilcon A), Biofinity Toric (P080011/S169)CooperVision, Inc.2024-07-30
enVista hydrophobic acrylic IOL, enVista toric hydrophobic acrylic IOL, enVista Aspire hydrophobic acrylic IOL, enVista (P910056/S054)Bausch & Lomb, Inc.2024-07-29
Light Adjustable Lens and Light Delivery Device (P160055/S038)Rxsight, Inc.2024-07-29
SofLens (polymacon) Contact Lens Family (N16895/S106)Bausch & Lomb, Inc.2024-07-25
Biofinity (comflicon A) (P080011/S168)CooperVision, Inc.2024-07-23
Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl (P860022/S060)Bausch & Lomb2024-07-18
Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S013)Bausch & Lomb2024-07-18
Biofinity Toric Multifocal and Biofinity XR Toric (comfilconA) (P080011/S166)CooperVision, Inc.2024-07-16
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S032)Alcon Laboratories, LLC2024-07-12
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S149)Alcon Laboratories, Inc.2024-07-12
AcrySof® ReSTOR Apodized Diffractive Optic Posterior Chamber IOL (P040020/S108)Alcon Research, Ltd.2024-07-12
THIXO (P200020/S006)Lenstec, Inc.2024-07-11
THIXO-1 Polishing Compound (P090022/S043)Lenstec, Inc.2024-07-11
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S020)CooperVision, Inc.2024-07-10
Biofinity Sphere, Biofinity XR Sphere, Biofinity Toric, Biofinity Multifocal, Biofinity Energys (P080011/S164)CooperVision, Inc.2024-07-09
Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric, Biofinity XR Toric, Biofinity Multifo (P080011/S165)CooperVision, Inc.2024-07-03
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030)Alcon Research, LLC2024-07-02
STAR S4 IR Excimer Laser (P930016/S065)Amo Manufacturing USA, LLC2024-07-01
Akreos Posterior Chamber Intraocular Lens (P060022/S033)Bausch & Lomb, Inc.2024-06-28
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S150)Alcon Laboratories, Inc.2024-06-20
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S109)Alcon Research, Ltd.2024-06-20
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon PanOptix Hydrophobic Acrylic IOL (P190018/S036)Alcon Laboratories, LLC2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
SENSAR® Soft Acrylic Posterior Chamber IOL (P980040/S168)Johnson & Johnson Surgical Vision, Inc.2024-06-17
TECNIS® Multifocal 3-Piece IOL, Model ZMA00 (P080010/S025)Johnson & Johnson Surgical Vision, Inc.2024-06-17
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17
TECNIS® Foldable Acrylic IOL with OptiEdge, Model ZA9003 (P990080/S060)Johnson & Johnson Surgical Vision, Inc.2024-06-17
PROVSIC™ Ophthalmic Viscosurgical Device (P890047/S064)Alcon Research, Ltd.2024-06-17
Biofinity Sphere (comfilcon A) (P080011/S163)CooperVision, Inc.2024-06-12
Clareon PanOptix Trifocal IOL (P190018/S034)Alcon Laboratories, LLC2024-06-11
Perfluoron (P950018/S028)Alcon Laboratories2024-06-11
Akreos Posterior Chamber Intraocular Lens (IOL) (P060022/S032)Bausch & Lomb, Inc.2024-06-07
The enVista® intraocular lens (IOL) (P910056/S055)Bausch & Lomb, Inc.2024-06-04
Silikon 1000 (P950008/S023)Alcon2024-06-03
MiSight 1 Day (omafilcon A) (P180035/S021)CooperVision, Inc.2024-05-31
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) and Clareon PanOptix Hydrophobic Acrylic IOL works (P190018/S035)Alcon Laboratories, LLC2024-05-31
VISTAKON (senoflicon A) Brand Contact Lenses (P040045/S137)Vistakon, Division of Johnson & Johnson Vision Car2024-05-30
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S107)Alcon Research, Ltd.2024-05-29
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S148)Alcon Laboratories, Inc.2024-05-29
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S031)Alcon Laboratories, LLC2024-05-29
Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S160)CooperVision, Inc.2024-05-24
VisuMax (P150040/S017)Carl Zeiss Meditec, Inc.2024-05-23
Biofinity Sphere and Sphere XR, Biofinity Energys Asphere, Biofinity Toric, Biofinity Torie XR, Biofinity Multifoeal (P080011/S162)CooperVision, Inc.2024-05-23
Biofinity Toric Multifocal, Biofinity Toric XR (P080011/S161)CooperVision, Inc.2024-05-23
Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO (P190018/S027)Alcon Laboratories, LLC2024-05-21
Biomedics 55 Asphere (ocufilcon D), Biomedics Torie (ocufilcon D) Soft (Hydrophilic) Contact Lenses for extended wear (P890023/S051)The Cooper Companies2024-05-16
Biofinity Sphere (comfilcon A), Biofinity Torie (comfilcon A), Biofinity XR Torie (comfilcon A), Biofinity Torie Multifo (P080011/S159)CooperVision, Inc.2024-05-16
Biomedics 55 Asphere (P890023/S050)The Cooper Companies2024-05-15
Lotrafilcon A and B soft Contact Lenses (P010019/S085)Alcon Laboratories, Inc.2024-05-15
Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C (P030016/S046)STAAR Surgical Company2024-05-10
Hydrus® Microstent (P170034/S012)Alcon Research, LLC2024-04-30
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S136)Vistakon, Division of Johnson & Johnson Vision Car2024-04-17
Precision7 ™, Precision7 ™ for Astigmatism, Precision7 ™ Multifocal, Precision7 ™ Multifocal Toric (P220007/S004)Alcon Laboratories, Inc.2024-04-17
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon Duet PRO Dual Pack (P810031/S075)Johnson & Johnson Surgical Vision, Inc.2024-04-15
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact (P040029/S022)Euclid Vision Corporation2024-04-15
Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S014)Johnson & Johnson Surgical Vision, Inc.2024-04-15
Light Adjustable Lens, Light Delivery Device (P160055/S035)Rxsight, Inc.2024-04-08
enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S053)Bausch & Lomb, Inc.2024-03-29
Akreos Posterior Chamber Intraocular Lens (P060022/S031)Bausch & Lomb, Inc.2024-03-28
iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100 (P080030/S026)Glaukos Corporation2024-03-28
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S063)Alcon Research, Ltd.2024-03-27
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S084)Alcon Laboratories2024-03-27
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S135)Vistakon, Division of Johnson & Johnson Vision Car2024-03-25
iDesign Refractive Studio (P930016/S066)Amo Manufacturing USA, LLC2024-03-22
Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta (P220007/S003)Alcon Laboratories, Inc.2024-03-21
iDesign Refractive Studio (iDesign/G301) (P930016/S064)Amo Manufacturing USA, LLC2024-03-21
Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric Intraocular Lenses, RayOne Aspheric RAO600C, RayOne Spheric RAO1 (P060011/S035)Rayner Intraocular Lenses , Ltd.2024-03-19
Light Adjustable Lens, Light Delivery Device (P160055/S034)Rxsight, Inc.2024-03-19
VisuMax & VISUMAX 800 (P150040/S015)Carl Zeiss Meditec, Inc.2024-03-18
MEL 80 Excimer Laser (P060004/S007)Carl Zeiss Meditec, Inc.2024-03-13
Clareon PanOptix Pro Trifocal IOLs (P190018/S030)Alcon Laboratories, LLC2024-03-05
MORCHER® EYEJET® CTR Single-Use Injector (P010059/S012)Morcher GmbH2024-03-01
enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S050)Bausch & Lomb, Inc.2024-02-22
WaveLight EX500 Laser (P030008/S038)Alcon Laboratories, Inc.2024-02-15
WaveLight EX500 Laser (P020050/S042)Alcon Laboratories, Inc.2024-02-15
Rayner c .. flex 570C, C-flex Aspheric 97 C, 600C Aspheric lntraocular lenses, RayOne Aspheric RAO600C, RayOne Spheric R (P060011/S036)Rayner Intraocular Lenses , Ltd.2024-02-12
Light Adjustable Lens and Light Delivery Device (P160055/S033)Rxsight, Inc.2024-02-08
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S134)Vistakon, Division of Johnson & Johnson Vision Car2024-02-05
ARTISAN Phakic lntraocular Lens (IOL), (P030028/S012)Ophtec BV2024-01-18
Capsular Tension Ring (CTR) (P030023/S011)Ophtec BV2024-01-18
VISUMAX 800 (P150040/S012)Carl Zeiss Meditec, Inc.2024-01-10
TECNIS Odyssey Toric II Intraocular Lens (IOL) With TECNIS Simplicity Delivery System, Models DRT150, DRT225, DRT300, DR (P980040/S159)Johnson & Johnson Surgical Vision, Inc.2023-12-22
TECNIS Symfony™ Extended Range Of Vision Intraocular Lens (P980040/S161)Johnson & Johnson Surgical Vision, Inc.2023-12-22
Biofinity Sphere, Biofinity Toric (P080011/S158)CooperVision, Inc.2023-12-20
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Every clearance here is in the API, with alerts when new ones post.