Atlas FDA

Ophthalmic

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

Sort:Newest firstOldest first

◉ Watch Ophthalmic

RecordFirmDate
Light Adjustable Lens, Light Delivery Device (P160055/S027)Rxsight, Inc.2023-02-16
Biofinity Sphere and Biofinity XR Sphere, Biofinity Energys, Biofinity Toric and Biofinity XR Toric, Biofinity Multifoca (P080011/S154)CooperVision, Inc.2023-02-15
CT LUCIA 621P (P100016/S009)Carl Zeiss Meditec Production, LLC2023-02-07
Light Adjustable Lens, Light Delivery Device (P160055/S022)Rxsight, Inc.2023-01-31
Qcellus Laser, Activis Laser, ZSL30 ACT, ZSL120 ACT, and HSBMBQ ACT Slit Lamp Adapters (P050026/S002)Bausch + Lomb Ireland Limited2023-01-20
Biofinity Sphere and Biofmity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S153)CooperVision, Inc.2023-01-19
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S015)CooperVision, Inc.2023-01-13
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S013)CooperVision, Inc.2023-01-12
Light Adjustable Lens, Light Delivery Device (P160055/S025)Rxsight, Inc.2023-01-12
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S014)CooperVision, Inc.2023-01-10
CT LUCIA Intraocular Lens (IOL) (P100016/S015)Carl Zeiss Meditec Production, LLC2023-01-05
IC-8® Apthera™ Intraocular Lens (IOL) (P210005/S003)Acu Focus, Inc.2022-12-23
Biofinity XR Toric and Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended wear (P080011/S152)CooperVision, Inc.2022-12-21
VisuMax Femtosecond Laser (P150040/S011)Carl Zeiss Meditec, Inc.2022-12-21
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S021)Alcon Laboratories, LLC2022-12-20
AcrySof® Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S144)Alcon Laboratories, Inc.2022-12-20
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S104)Alcon Research, Ltd.2022-12-20
VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S129)Vistakon, Division of Johnson & Johnson Vision Car2022-12-19
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S110)Vistakon, Johnson & Johnson Vision Products, Inc.2022-12-16
TECNIS 1-Piece IOL with TECNIS® iTEC Preloaded Delivery System Model PCB00, TECNIS Multifocal 1-PC IOL with TECNIS® iTEC (P980040/S154)Johnson & Johnson Surgical Vision, Inc.2022-12-15
TECNIS Eyhance™ IOL with TECNIS Simplicity™ Delivery System, Model DIB00, TECNIS Eyhance™ Toric II IOLs with TECNIS Simp (P980040/S155)Johnson & Johnson Surgical Vision, Inc.2022-12-12
BIOFINITY Sphere and Biofinity Toric (COMFILCON A) Soft Contact Lenses for Extended Wear (P080011/S151)CooperVision, Inc.2022-12-07
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S012)CooperVision, Inc.2022-12-07
TECNIS® CL Foldable Silicone Posterior Chamber IOL (P880081/S047)Johnson & Johnson Surgical Vision, Inc.2022-12-06
SENSAR® 3-Piece Monofocal IOLs, SENSAR 1-Piece IOL, TECNIS Monofocal 1-Piece IOL, TECNIS Multifocal 1-Piece IOL, TECNIS (P980040/S153)Johnson & Johnson Surgical Vision, Inc.2022-12-06
TECNIS® Multifocal Foldable Posterior Chamber IOL (P080010/S021)Johnson & Johnson Surgical Vision, Inc.2022-12-06
TECNIS® Foldable Acrylic IOL (P990080/S056)Johnson & Johnson Surgical Vision, Inc.2022-12-06
IC-8 Apthera Intraocular Lens (IOL) (P210005/S004)Acu Focus, Inc.2022-12-02
Light Adjustable Lens, Light Delivery Device (P160055/S026)Rxsight, Inc.2022-11-30
Biofinity, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses (P080011/S150)CooperVision, Inc.2022-11-21
SBL-3 Multifocal Intraocular Lens (P200020/S002)Lenstec, Inc.2022-11-17
SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0 (P980040/S152)Johnson & Johnson Surgical Vision, Inc.2022-11-17
Menicon Z (tisilfocon) Rigid Gas Permeable Contact Lens and Menicon Z Night (tisilfocon A) Contact Lenses for Overnight (P990018/S007)Menicon Co, Ltd.2022-11-16
iStent inject W Trabecular Micro-Bypass System (P170043/S013)Glaukos Corporation2022-11-07
AcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L (P930014/S141)Alcon Laboratories, Inc.2022-11-02
AcrySof Posterior Chamber Intraocular Lens (P930014/S138)Alcon Laboratories, Inc.2022-10-28
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (P040020/S100)Alcon Research, Ltd.2022-10-28
JJSV's One-Piece IOL's with Daisy-Whell packaging configuration, JJSV's One-Piece IOLs with TECNIS SmartLOAD Delivery Te (P980040/S151)Johnson & Johnson Surgical Vision, Inc.2022-10-27
Biofinity Toric (comfilcon A) soft (hydrophilic) Contact Lenses for Extended Wear (P080011/S149)CooperVision, Inc.2022-10-26
SENSAR® 1-piece IOL, TECNIS® 1-Piece IOL, SENSAR® 1-piece IOL with SmartLOADTM Delivery Technology, TECNIS® 1-piece IOL (P980040/S150)Johnson & Johnson Surgical Vision, Inc.2022-10-07
BIOLON® (P960011/S034)Altacor , Ltd.2022-10-03
Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P980006/S035)Bausch & Lomb, Inc.2022-09-29
Biomedics 55 Asphere (ocufilcon D) Soft (Hydrophilic) Contact Lenses for Extended Wear (P890023/S049)The Cooper Companies2022-09-23
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S011)CooperVision, Inc.2022-09-22
VISTAKON® (etafilcon A) Brand Contact Lenses (N18033/S109)Vistakon, Johnson & Johnson Vision Products, Inc.2022-09-22
CELLUGEL® Ophthalmic Viscosurgical Devices (P990023/S018)Alcon Laboratories2022-09-22
VISTAKON® (senofilcon A) Brand Contact Lenses (P040045/S127)Vistakon, Division of Johnson & Johnson Vision Car2022-09-22
Akreos® Posterior Chamber Intraocular Lens (IOL) (P060022/S030)Bausch & Lomb, Inc.2022-09-20
IC-8 Apthera Intraocular Lens (IOL) (P210005/S002)Acu Focus, Inc.2022-09-20
IC-8 Apthera Intraocular Lens (IOL) (P210005/S001)Acu Focus, Inc.2022-09-20
Ethos AquaTech Monthly XR, Ethos AquaTech Monthly XR for Astigmatism (P080011/S141)CooperVision, Inc.2022-09-19
SBL-3 Intraocular Lens (P200020/S001)Lenstec, Inc.2022-09-16
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), (P840064/S078)Alcon Laboratories2022-09-15
CELLUGEL OVD (P990023/S017)Alcon Laboratories2022-09-15
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S059)Alcon Research, Ltd.2022-09-15
MiSight 1 day (omafilcon A) (P180035/S010)CooperVision, Inc.2022-09-15
PROVISC™ Ophthalmic Viscosurgical Device (P890047/S058)Alcon Research, Ltd.2022-09-13
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System (consists of PROVISC™ and VISCOAT™), (P840064/S077)Alcon Laboratories2022-09-13
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S128)Vistakon, Division of Johnson & Johnson Vision Car2022-09-01
iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi (P170043/S014)Glaukos Corporation2022-08-29
iStent Trabecular Micro-Bypass Stent System, iStent inject Trabecular Micro-Bypass System, iStent inject W Trabecular Mi (P080030/S024)Glaukos Corporation2022-08-29
Biofinity XR Toric, Biofinity Toric Multifocal (P080011/S148)CooperVision, Inc.2022-08-18
Sofmed breathables XW Extended Parameters, Sofmed breathables XW toric Extended Parameters (P080011/S144)CooperVision, Inc.2022-08-15
Natural Eyes HydraWear XW Extended Parameters, Natural Eyes HydraWear XW for Astigmatism Extended Parameters (P080011/S142)CooperVision, Inc.2022-08-15
C-Flex 570C, C-Flex Aspheric 970C, 600C Aspheric Intraocular Lenses (P060011/S030)Rayner Intraocular Lenses , Ltd.2022-08-15
Perfluoron™ (P950018/S021)Alcon Laboratories2022-08-12
PMMA Anterior Chamber Intraocular Lenses (P840039/S064)Bausch & Lomb, Inc.2022-08-09
Biofinity Sphere, Biofinity Toric (P080011/S147)CooperVision, Inc.2022-08-08
ISPAN Perfluoropropane C3F8 Gas (P900066/S014)Airgas Therapeutics, LLC2022-08-04
Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear; ACUVUE® Abiliti™ Overnight and ACUVUE® Abiliti™ Overni (P990018/S008)Menicon Co, Ltd.2022-08-02
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S146)CooperVision, Inc.2022-07-25
TECNIS® Symfony™, TECNIS® Symfony™ Toric, TECNIS® Symfony™ OptiBlue®, TECNIS® Symfony™ OptiBlue® with TECNIS Simplicity® (P980040/S149)Johnson & Johnson Surgical Vision, Inc.2022-07-25
IC-8 Apthera Intraocular Lens (IOL) (P210005)Acu Focus, Inc.2022-07-22
SBL-3 Multifocal Intraocular Lens (P200020)Lenstec, Inc.2022-07-22
Artisan Myopia (P030028/S009)Ophtec BV2022-07-22
RingJect and Capsular Tension Ring (CTR) (P030023/S008)Ophtec BV2022-07-21
TECNIS Eyhance™ Toric II, Model ICU, TECNIS Eyhance™ Toric II with TECNIS Simplicity® Delivery System, TECNIS Synergy™ T (P980040/S148)Johnson & Johnson Surgical Vision, Inc.2022-07-20
CT Lucia 602 (P100016/S011)Carl Zeiss Meditec Production, LLC2022-07-14
Lotrafilcon A and B Soft Contact Lenses (P010019/S083)Alcon Laboratories, Inc.2022-07-06
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S023)Rxsight, Inc.2022-07-05
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S126)Vistakon, Division of Johnson & Johnson Vision Car2022-06-22
VisuMax Femtosecond Laser (P150040/S010)Carl Zeiss Meditec, Inc.2022-06-17
FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid (P870024/S060)CooperVision, Inc.2022-06-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S125)Vistakon, Division of Johnson & Johnson Vision Car2022-06-15
Biofinity Toric Multifocal (P080011/S139)CooperVision, Inc.2022-06-09
Paragon CRT®, Paragon CRT®100, Paragon CRT Dual Axis®, Paragon RG-4™ Rigid Gas Permeable Contact Lenses in Clear and Tin (P870024/S059)CooperVision, Inc.2022-06-08
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens (P170035/S017)Bausch and Lomb, Inc.,2022-06-01
Biomedics 55 Asphere (P890023/S048)The Cooper Companies2022-05-24
EVO/EVO+ VISIAN® Implantable Collamer® Lenses (P030016/S042)STAAR Surgical Company2022-05-20
JJSV’s intraocular lenses (IOLs) (P980040/S147)Johnson & Johnson Surgical Vision, Inc.2022-05-18
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S103)Alcon Research, Ltd.2022-05-18
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018/S020)Alcon Laboratories, LLC2022-05-18
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S143)Alcon Laboratories, Inc.2022-05-18
CT Lucia 602, CT Lucia 202, CT Lucia 611P (P100016/S014)Carl Zeiss Meditec Production, LLC2022-05-13
Paragon Z CRT, Paragon Z CRT Dual Axis (P050031/S009)CooperVision, Inc.2022-05-10
Paragon CRT Paragon CRT 100, Paragon CRT Dual Axis and Paragon RG-4 Rigid Rigid Gas Permeable Contact Lenses in Clear an (P870024/S062)CooperVision, Inc.2022-05-10
EVO/EVO+ VISIAN® Implantable Collamer® Lenses (P030016/S043)STAAR Surgical Company2022-05-04
Biofinity Sphere, Biofinity Toric, Biofinity Energys, and Biofinity Multifocal (comfilcon A) Soft (Hydrophilic) Contact (P080011/S145)CooperVision, Inc.2022-05-03
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens with the AutonoMe Pre-Loaded Delivery System, Clareon Toric Aspher (P190018/S019)Alcon Laboratories, LLC2022-05-03
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S124)Vistakon, Division of Johnson & Johnson Vision Car2022-04-27
← Previous Next →

Track Ophthalmic automatically

Every clearance here is in the API, with alerts when new ones post.