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Ophthalmic

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

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RecordFirmDate
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S006)Alcon Research, LLC2025-04-30
IC-8 Apthera Intraocular Lens (IOL) (P210005/S007)Acu Focus, Inc.2025-04-25
Light Adjustable Lens, Light Delivery Device (P160055/S043)Rxsight, Inc.2025-04-17
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S040)Rayner Intraocular Lenses , Ltd.2025-04-09
SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses (P960022/S013)Bausch & Lomb, Inc.2025-04-08
AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS,MODEL ADAPT (P060022/S034)Bausch & Lomb, Inc.2025-04-02
Biofinity Sphere (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S185)CooperVision, Inc.2025-03-25
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S005)Alcon Research, LLC2025-03-24
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S005)Alcon Research, LLC2025-03-24
AcrySof Posterior Chamber Intraocular Lenses (P930014/S154)Alcon Laboratories, Inc.2025-03-21
BIOFINITY (COMFILCON A) (P080011/S183)CooperVision, Inc.2025-03-17
Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens (P980006/S037)Bausch & Lomb, Inc.2025-03-17
H55 HYDROPHILIC CONTACT LENS (P890023/S054)The Cooper Companies2025-03-17
Biofinity Sphere and Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S182)CooperVision, Inc.2025-03-12
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S053)The Cooper Companies2025-03-12
Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD (P810031/S079)Johnson & Johnson Surgical Vision, Inc.2025-03-11
IC-8 Apthera IOL Aperture Mask (P210005/S009)Acu Focus, Inc.2025-03-07
EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), (P030016/S047)STAAR Surgical Company2025-03-05
WaveLight EX500 Laser (P020050/S043)Alcon Laboratories, Inc.2025-03-05
PROVSIC Ophthalmic Viscosurgical Device (P890047/S067)Alcon Research, Ltd.2025-02-26
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
BIOFINITY (COMFILCON A) (P080011/S181)CooperVision, Inc.2025-02-25
iStent inject® W Trabecular Micro-Bypass System Model iS2 (P170043/S019)Glaukos Corporation2025-02-24
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S025)CooperVision, Inc.2025-02-20
Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment (P010062/S014)Bausch & Lomb2025-02-20
AcrySof Posterior Chamber Intraocular Lens (IOL) (P930014/S155)Alcon Laboratories, Inc.2025-02-14
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S004)Alcon Research, LLC2025-02-14
Light Adjustable Lens and Light Delivery Device (P160055/S042)Rxsight, Inc.2025-02-14
AcrySof ReSTOR Posterior Chamber Intraocular Lens (IOL) (P040020/S113)Alcon Research, Ltd.2025-02-14
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S004)Alcon Research, LLC2025-02-14
Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy (P080011/S179)CooperVision, Inc.2025-02-14
Quantel Activis Laser, Modulight ML6710i Laser and ML-SLA, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters (P050026/S003)Bausch + Lomb Ireland Limited2025-02-11
TENEO 317 Model 2 (P990027/S025)Technolas Perfect Vision GmbH2025-02-06
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S139)Vistakon, Division of Johnson & Johnson Vision Car2025-02-05
RayOne EMV (P060011/S037)Rayner Intraocular Lenses , Ltd.2025-02-05
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S153)Alcon Laboratories, Inc.2025-02-04
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S040)Alcon Laboratories, LLC2025-02-04
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S112)Alcon Research, Ltd.2025-02-04
TENEO 317 Model 2 (P990027/S023)Technolas Perfect Vision GmbH2025-02-04
Biofinity Sphere and Biofinity XR Sphere, Biofinity Torie and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energ (P080011/S178)CooperVision, Inc.2025-02-04
Hydrus Microstent (P170034/S013)Alcon Research, LLC2025-01-30
Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens (P980006/S036)Bausch & Lomb, Inc.2025-01-16
WaveLight EX500 Laser System (P030008/S039)Alcon Laboratories, Inc.2025-01-16
WaveLight EX500 Laser System (P020050/S044)Alcon Laboratories, Inc.2025-01-16
Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S016)Johnson & Johnson Surgical Vision, Inc.2025-01-15
Healon Duet® PRO Dual Pack (P810031/S077)Johnson & Johnson Surgical Vision, Inc.2025-01-15
Rayner C-flex 570C, C-flex Aspheric 970C, G00C Aspheric lntraocular lenses, RayOne Aspheric RAOG00C, RayOne Spheric RAOl (P060011/S038)Rayner Intraocular Lenses , Ltd.2025-01-14
TECNIS SIMPILICITY™ Delivery System, SmartLOAD Delivery Technology (P980040/S170)Johnson & Johnson Surgical Vision, Inc.2025-01-14
enVista hydrophobic acrylic intraocular lens (IOL), enVista toric hydrophobic acrylic intraocular lens (IOL), enVista As (P910056/S058)Bausch & Lomb, Inc.2025-01-14
enVista Envy hydrophobic acrylic intraocular lens (IOL), enVista Envy toric hydrophobic acrylic intraocular lens (IOL) (P240005/S001)Bausch & Lomb, Inc.2025-01-14
iStent inject Trabecular MicroBypass System (P170043/S020)Glaukos Corporation2025-01-13
Precision7™, Precision7™ for Astigmatism, Precision7™ Multifocal, Precision7™ Multifocal Toric (P220007/S006)Alcon Laboratories, Inc.2025-01-06
Biofinity XR Toric and Biofinity Toric Multifocal comfilcon A Soft (Hydrophilic) Contact Lenses (P080011/S177)CooperVision, Inc.2025-01-02
Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate) (P110007/S015)Johnson & Johnson Surgical Vision, Inc.2024-12-23
Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le (P040029/S024)Euclid Vision Corporation2024-12-23
Sodium Hyaluronate Ophthalmic Viscoelastic Device (OVD), Healon Duet® PRO Dual Pack (P810031/S076)Johnson & Johnson Surgical Vision, Inc.2024-12-23
Hydrus Microstent (P170034/S014)Alcon Research, LLC2024-12-20
TECNIS 3-Piece Acrylic Monofocal (P990080/S061)Johnson & Johnson Surgical Vision, Inc.2024-12-19
SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, TECNIS Opt (P980040/S169)Johnson & Johnson Surgical Vision, Inc.2024-12-19
TECNIS 3-Piece Multifocal (P080010/S026)Johnson & Johnson Surgical Vision, Inc.2024-12-19
BIOFINITY (COMFILCON A) (P080011/S175)CooperVision, Inc.2024-12-18
H55 HYDROPHILIC CONTACT LENS (P890023/S052)The Cooper Companies2024-12-18
BIOFINITY Toric (COMFILCON A) soft (hydrophilic) contact lenses for extended wear (P080011/S176)CooperVision, Inc.2024-12-18
Implantable Miniature Telescope (IMT) (P050034/S021)Samsara Vision, Inc.2024-12-17
Light Adjustable Lens, Light Delivery Device (P160055/S041)Rxsight, Inc.2024-12-16
TENEO 317 Model 2 (P990027/S024)Technolas Perfect Vision GmbH2024-12-16
Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric UV Absorbing Intraocular Lens (P190018/S038)Alcon Laboratories, LLC2024-12-16
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S003)Alcon Research, LLC2024-12-13
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S003)Alcon Research, LLC2024-12-13
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005/S002)Bausch & Lomb, Inc.2024-12-11
MEL90 (P060004/S006)Carl Zeiss Meditec, Inc.2024-12-04
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S002)Alcon Research, LLC2024-12-02
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S002)Alcon Research, LLC2024-12-02
Light Adjustable Lens and Light Delivery Device (P160055/S037)Rxsight, Inc.2024-12-02
Ethos AquaTech Evolve Monthly (P080011/S167)CooperVision, Inc.2024-11-15
Artisan Myopia (P030028/S010)Ophtec BV2024-11-15
TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) (P990027/S022)Technolas Perfect Vision GmbH2024-11-06
Morcher Capsular Tension Ring (P010059/S008)Morcher GmbH2024-11-04
Light Adjustable Lens, Light Delivery Device (P160055/S040)Rxsight, Inc.2024-10-31
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S138)Vistakon, Division of Johnson & Johnson Vision Car2024-10-30
BIOFINITY (COMFILCON A) (P080011/S174)CooperVision, Inc.2024-10-29
Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S172)CooperVision, Inc.2024-10-24
UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery (P220030/S001)Alcon Research, LLC2024-10-22
UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy (P230012/S001)Alcon Research, LLC2024-10-22
Biofinity Sphere and Biofinity XR Sphere, Biofinity Toric and Biofinity XR Toric, Biofinity Multifocal, Biofinity Energy (P080011/S173)CooperVision, Inc.2024-10-22
VisuMax Femtosecond Laser (P150040/S018)Carl Zeiss Meditec, Inc.2024-10-16
MFK IOL (P200020/S007)Lenstec, Inc.2024-10-11
HQL Softec HD, Softec I, Softec HD PS, Softec HDO, Softec HDM (P090022/S044)Lenstec, Inc.2024-10-11
VisuMax (P150040/S016)Carl Zeiss Meditec, Inc.2024-10-11
enVista Envy™ hydrophobic acrylic intraocular lens (IOL), enVista Envy™ toric hydrophobic acrylic intraocular lens (IOL) (P240005)Bausch & Lomb, Inc.2024-10-10
MiSight 1 Day (omafilcon A) (P180035/S024)CooperVision, Inc.2024-10-07
EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO), (P030016/S045)STAAR Surgical Company2024-10-01
TECNIS® 3-Piece Acrylic Monofocal (P990080/S057)Johnson & Johnson Surgical Vision, Inc.2024-09-27
TECNIS® CL Foldable Silicone IOL (P880081/S048)Johnson & Johnson Surgical Vision, Inc.2024-09-27
TECNIS 1-Piece IOL with TECNIS® iTec Preloaded Delivery System, SENSAR® 3-Piece Monofocal IOL (P980040/S160)Johnson & Johnson Surgical Vision, Inc.2024-09-27
TECNIS® 3-Piece Multifocal (P080010/S022)Johnson & Johnson Surgical Vision, Inc.2024-09-27
Biofinity XR Sphere, Biofinity Energys Asphere, Biofinity Toric and Biofinity XR Torie and Biofinity Multifocal (comfilc (P080011/S171)CooperVision, Inc.2024-09-17
INTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS (P980031/S013)Addition Technology2024-09-09
enVista Hydrophobic Acrylic Intraocular Lens (P910056/S057)Bausch & Lomb, Inc.2024-09-06
Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta (P220007/S005)Alcon Laboratories, Inc.2024-09-04
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Every clearance here is in the API, with alerts when new ones post.