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Ophthalmic

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

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RecordFirmDate
SofLens Toric (alphafilcon A) Contact Lenses (P960022/S012)Bausch & Lomb, Inc.2020-04-13
SofLens (polymacon) Contact Lenses (N16895/S103)Bausch & Lomb, Inc.2020-04-13
CyPass Micro-Stent (P150037/S014)Alcon Research, Ltd.2020-04-09
DUOVISC Ophthalmic Viscoelastic System (consists of PROVISC and VISCOAT), DISCOVISC Ophthalmic Viscosurgical Device (P840064/S071)Alcon Laboratories2020-04-02
PROVISC Ophthalmic Viscosurgical Device (P890047/S054)Alcon Research, Ltd.2020-04-02
VisuMax Femtosecond Laser (P150040/S005)Carl Zeiss Meditec, Inc.2020-04-02
Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S104)CooperVision, Inc.2020-04-01
Visian Implantable Collamer Lens (P030016/S040)STAAR Surgical Company2020-03-31
Collamer Intraocular Lens (P990013/S040)Starr Surgical Co.2020-03-31
C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens, and RayOne Aspheric (P060011/S020)Rayner Intraocular Lenses , Ltd.2020-03-30
enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S039)Bausch & Lomb, Inc.2020-03-26
Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S103)CooperVision, Inc.2020-03-24
Lotrafilcon A Soft Contact Lenses and Lotrafilcon B Soft Contact Lenses (P010019/S076)Alcon Laboratories, Inc.2020-03-19
iSert Preloaded IOL System, Intraocular Lens - Clarisert (P080004/S032)Hoya Surgical Optics, Inc.2020-03-12
Frequency 55 (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P850079/S086)CooperVision, Inc.2020-03-12
Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S102)CooperVision, Inc.2020-03-12
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S005)CooperVision, Inc.2020-03-12
Tecnis Multifocal Toric II Intraocular Lenses (IOL) (P980040/S107)Johnson & Johnson Surgical Vision, Inc.2020-02-28
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil (P040029/S012)Euclid Vision Corporation2020-02-28
AcrySof™ IQ Vivity™ Extended Vision, Toric Extended Vision, Extended Vision UV Absorbing, and Toric Extended Vision UV A (P930014/S126)Alcon Laboratories, Inc.2020-02-26
C-flex lntraocular Lens, C-flex Aspheric lntraocular Lens, 6.0 mm Aspheric lntraocular Lens and RayOne Aspheric (P060011/S019)Rayner Intraocular Lenses , Ltd.2020-02-21
ocufilcon D soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S042)The Cooper Companies2020-02-14
iDESIGN Refractive Studio (P930016/S061)Amo Manufacturing USA, LLC2020-02-14
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S001)CooperVision, Inc.2020-02-05
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses (P180035/S002)CooperVision, Inc.2020-02-04
Pearle Vision Monthly Multifocal (P080011/S098)CooperVision, Inc.2020-01-28
iDESIGN Refractive Studio (P930016/S060)Amo Manufacturing USA, LLC2020-01-28
Hydrus Microstent (P170034/S004)Alcon Research, LLC2020-01-23
Lotrafilcon A and B Soft contact lenses for extended wear (P010019/S075)Alcon Laboratories, Inc.2020-01-22
Akreos One-Piece Acrylic Intraocular Lens (IOL) (P060022/S025)Bausch & Lomb, Inc.2020-01-21
enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S041)Bausch & Lomb, Inc.2020-01-21
enVista One Piece Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S040)Bausch & Lomb, Inc.2020-01-16
Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint (P050031/S004)CooperVision, Inc.2020-01-10
AcrySof IQ Aspheric IOL with the UltraSert Pre-Loaded Delivery System (P930014/S124)Alcon Laboratories, Inc.2020-01-09
Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon Toric Aspheric Hydrophobic Acrylic Intraocular Lens (P190018)Alcon Laboratories, LLC2020-01-07
AcrySof Intraocular Lenses (P930014/S120)Alcon Laboratories, Inc.2019-12-30
iSert Preloaded IOL Models, iSymm, Clarisert IOL Models (P080004/S029)Hoya Surgical Optics, Inc.2019-12-30
Biomedics 55 Asphere (ocufilcon D) Extended Wear Soft Contact Lenses (P890023/S040)The Cooper Companies2019-12-18
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S112)Vistakon, Division of Johnson & Johnson Vision Car2019-12-18
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S007)Bausch and Lomb, Inc.,2019-12-18
Biofinity (comfilcon A) Toric Multifocal Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S100)CooperVision, Inc.2019-12-17
WaveLight EX500 Laser System/Allegro Topolyzer Vario (P030008/S030)Alcon Laboratories, Inc.2019-12-13
Hydrus Microstent (P170034/S003)Alcon Research, LLC2019-12-13
WaveLight EX500 Laser System/Allegro Topolyzer Vario (P020050/S034)Alcon Laboratories, Inc.2019-12-13
Lotrafilcon B soft contact lenses for extended wear (P010019/S074)Alcon Laboratories, Inc.2019-12-12
Hydrus Microstent (P170034/S002)Alcon Research, LLC2019-12-10
iSert Preloaded System, iSpheric, iSymm IOL Models, Clarisert Preloaded System (P080004/S027)Hoya Surgical Optics, Inc.2019-12-04
iSymm, iSpheric IOL (P080004/S026)Hoya Surgical Optics, Inc.2019-12-04
iSert Preloaded System/ iSert Micro Injector (P080004/S025)Hoya Surgical Optics, Inc.2019-11-29
Lotrafilcon A and B Soft Contact Lenses for Extended Wear (P010019/S072)Alcon Laboratories, Inc.2019-11-27
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S008)Rxsight, Inc.2019-11-22
SENSAR/TECNIS 1-piece IOL with SmartLOAD Delivery Technology, TECNIS Optiblue 1-Piece IOL with SmartLOAD Delivery Techno (P980040/S110)Johnson & Johnson Surgical Vision, Inc.2019-11-22
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035)CooperVision, Inc.2019-11-15
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S039)The Cooper Companies2019-11-14
methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S085)CooperVision, Inc.2019-11-14
Menicon Z Night (tisilfocon A) Contact Lenses for Overnight Wear (P990018/S005)Menicon Co, Ltd.2019-11-06
Frequency 55 Toric (methafilcon A) (P850079/S081)CooperVision, Inc.2019-10-25
HOYA iSert 250/251 and Clarisert Pre-Loaded IOL Injector System (P080004/S023)Hoya Surgical Optics, Inc.2019-10-25
Biofinity XR Toric (comfilcon A) (P080011/S087)CooperVision, Inc.2019-10-25
Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S009)Euclid Vision Corporation2019-10-24
TECNIS Toric II 1-Piece Intraocular Lenses and TECNIS Symfony Toric II Extended Range of Vision Introacular Lensses (P980040/S103)Johnson & Johnson Surgical Vision, Inc.2019-10-23
Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, Mu (P980040/S108)Johnson & Johnson Surgical Vision, Inc.2019-10-15
Tecnis 3-Piece Acrylic Monofocal (P990080/S051)Johnson & Johnson Surgical Vision, Inc.2019-10-15
PureVision (balafilcon A) Contact Lens (P980006/S029)Bausch & Lomb, Inc.2019-10-10
AcrySof Posterior Chamber Intraocular Lens (P930014/S128)Alcon Laboratories, Inc.2019-10-10
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S092)Alcon Research, Ltd.2019-10-10
Ultra (samfilcon A) Contact Lens (P170035/S005)Bausch and Lomb, Inc.,2019-10-10
Silsoft (elastofilcon A) Contact Lens (P850068/S013)Bausch & Lomb, Inc.2019-10-10
Biofinity Toric (P080011/S099)CooperVision, Inc.2019-10-09
Raindrop Near Vision Inlay (P150034/S008)Rvo 2.0, Inc. (D.B.A. Optics Medical)2019-10-09
Hydrus Microstent (P170034/S001)Alcon Research, LLC2019-10-08
CustomFlex Artificial Iris (P170039/S002)Humanoptics AG2019-10-03
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S033)Alcon Laboratories, Inc.2019-10-03
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S029)Alcon Laboratories, Inc.2019-10-03
Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens (P980040/S098)Johnson & Johnson Surgical Vision, Inc.2019-10-01
VISTAKON (senofilcon A) - ACUVUE OASYS for Astigmatism Brand Contact Lenses (P040045/S110)Vistakon, Division of Johnson & Johnson Vision Car2019-09-26
AcrySof Intraocular Lenses (P930014/S127)Alcon Laboratories, Inc.2019-09-24
CustomFlex Artificial Iris (P170039/S001)Humanoptics AG2019-09-23
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S085)CooperVision, Inc.2019-09-18
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S007)Rxsight, Inc.2019-09-18
The SENSAR/TECNIS 1-Piece IOL with SmartLOAD Delivery Technology and The TECNIS OptiBlue 1-Piece IOL with SmartLOAD Deli (P980040/S095)Johnson & Johnson Surgical Vision, Inc.2019-09-13
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophillic) Contact Lenses (P170035/S006)Bausch and Lomb, Inc.,2019-09-12
TECNIS iTEC Preloaded Delivery System (P980040/S106)Johnson & Johnson Surgical Vision, Inc.2019-09-11
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S097)CooperVision, Inc.2019-09-10
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S038)The Cooper Companies2019-09-10
polymacon Soft (Hydrophilic) Extended Wear Contact Lenses (P780007/S062)CooperVision, Inc.2019-09-10
STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio (P930016/S057)Amo Manufacturing USA, LLC2019-09-09
enVista Hydrophobic Acrylic Intraocular Lens (P910056/S037)Bausch & Lomb, Inc.2019-09-06
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S084)CooperVision, Inc.2019-09-05
Comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S096)CooperVision, Inc.2019-09-05
Lotrafilcon A and B Soft Contact Lenses (P010019/S073)Alcon Laboratories, Inc.2019-08-30
TECNIS iTEC Preloaded Delivery System (P980040/S100)Johnson & Johnson Surgical Vision, Inc.2019-08-29
Ophthalmic Viscoelastic (P000046/S027)Anika Therapeutics, Inc.2019-08-28
AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens (P040020/S087)Alcon Research, Ltd.2019-08-26
iSert Intraocular Lenses (IOLs) (P080004/S024)Hoya Surgical Optics, Inc.2019-08-21
AcrySoft Intraocular Lenses (P930014/S125)Alcon Laboratories, Inc.2019-08-19
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S095)CooperVision, Inc.2019-08-09
Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco (P040029/S006)Euclid Vision Corporation2019-08-07
TECNIS iTec Preloaded Delivery System (P980040/S105)Johnson & Johnson Surgical Vision, Inc.2019-08-07
enVista Hydrophobic Acrylic Intraocular Lens (IOL) (P910056/S038)Bausch & Lomb, Inc.2019-08-06
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