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Ophthalmic

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

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RecordFirmDate
RxSight Light Adjustable Lens and Light Delivery Device (P160055/S005)Rxsight, Inc.2019-08-06
BIOLON (P960011/S032)Altacor , Ltd.2019-08-05
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S091)Alcon Research, Ltd.2019-08-01
Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lenses (P170035/S004)Bausch and Lomb, Inc.,2019-08-01
PMMA Multi-Piece Posterior Chamber Intraocular Lens (P810032/S070)Alcon Laboratories2019-08-01
PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S047)Alcon Laboratories2019-08-01
AcrySof Posterior Chamber Intraocular Lens and Delivery Systems (P930014/S123)Alcon Laboratories, Inc.2019-08-01
PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S029)Alcon Laboratories2019-08-01
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S018)Rayner Intraocular Lenses , Ltd.2019-07-31
Visian Implantable Collamer Lens (P030016/S039)STAAR Surgical Company2019-07-26
Collamer Intraocular Lens - Alternat Environmental Monitoring Provider (P990013/S039)Starr Surgical Co.2019-07-26
ReSure Sealant (P130004/S007)Ocular Therapeutix, Inc.2019-07-25
VisuMax Femtosecond Laser (P150040/S004)Carl Zeiss Meditec, Inc.2019-07-25
NanoFLEX One Piece Collamer Intraocular Lens (CIOL) (P990013/S038)Starr Surgical Co.2019-07-19
Visian ICL Implantable Collamer Lens (ICL) (P030016/S037)STAAR Surgical Company2019-07-19
Visian Toric ICL (Implantable Collamer Lens) (P030016/S038)STAAR Surgical Company2019-07-19
Euclid Systems Orthokeratology (oprifocon A) and (tisilfocon A) Contact Lenses for Overnight Wear (P040029/S008)Euclid Vision Corporation2019-07-18
Sensar 1-Piece IOL, Tecnis 1-Piece IOL, OptiBlue 1-Piece IOL, iTec Preloaded Delivery System, Multifocal 1-Piece IOL, To (P980040/S104)Johnson & Johnson Surgical Vision, Inc.2019-07-18
Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Rigid Gas Permeable Contact lenses in blue tint (P050031/S005)CooperVision, Inc.2019-07-11
Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu (P870024/S051)CooperVision, Inc.2019-07-11
enVista One Piece Hydrophobic Acrylic Intraocular Lens (P910056/S032)Bausch & Lomb, Inc.2019-07-03
FluoroPerm 92, FluoroPerm 60, FluoroPerm 30, FluoroPerm 151, HDS and HDS 100 (P870024/S052)CooperVision, Inc.2019-07-03
enVista One Piece Hydrophobic Acrylic Intraocular Lens (P910056/S036)Bausch & Lomb, Inc.2019-07-02
TECNIS CL Foldable Silicone Intraocular Lens (P880081/S043)Johnson & Johnson Surgical Vision, Inc.2019-06-27
TECNIS Symfony Toric Extended Range of Vision Intraocular Lens (P980040/S099)Johnson & Johnson Surgical Vision, Inc.2019-06-26
RxSight Light Adjustable Lens: Ligh Delivery Device (P160055/S006)Rxsight, Inc.2019-06-20
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S109)Vistakon, Division of Johnson & Johnson Vision Car2019-06-12
Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S094)CooperVision, Inc.2019-06-10
Methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S083)CooperVision, Inc.2019-06-10
Vistakon (etafilcon A) Brand Contact Lenses (N18033/S105)Vistakon, Johnson & Johnson Vision Products, Inc.2019-06-07
VISTAKON (etafilcon A) Brand Contact Lenses. (N18033/S101)Vistakon, Johnson & Johnson Vision Products, Inc.2019-05-31
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S093)CooperVision, Inc.2019-05-31
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S004)Glaukos Corporation2019-05-30
Vistakon (etafilcon A) Brand Contact Lenses (N18033/S104)Vistakon, Johnson & Johnson Vision Products, Inc.2019-05-29
Achromatizing ReSTOR 2.5 Intraocular Lenses (IOLs) (P040020/S088)Alcon Research, Ltd.2019-05-28
iDESIGN Refractive Studio and STAR S4 IR Excimer Laser Systems (P930016/S059)Amo Manufacturing USA, LLC2019-05-28
Paragon Z CRT (tisilfocon A) and Paragon Z CRT Dual Axis (tisilfocon A) Contact Lenses (P050031/S003)CooperVision, Inc.2019-05-28
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S108)Vistakon, Division of Johnson & Johnson Vision Car2019-05-22
Vistakon (etafilcon A) Brand Contact Lenses (N18033/S103)Vistakon, Johnson & Johnson Vision Products, Inc.2019-05-17
Vistakon (senofilcon A) Brand Contact Lenses (P040045/S107)Vistakon, Division of Johnson & Johnson Vision Car2019-05-17
Artisan Myopia Intraocular Lens (P030028/S008)Ophtec BV2019-05-14
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S092)CooperVision, Inc.2019-05-08
methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S082)CooperVision, Inc.2019-05-08
BAUSCH + LOMB Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens (P170035/S003)Bausch and Lomb, Inc.,2019-05-08
iDESIGN Refractive Studio (P930016/S058)Amo Manufacturing USA, LLC2019-05-03
BIOLON (P960011/S031)Altacor , Ltd.2019-05-01
RingJect (P030023/S006)Ophtec BV2019-04-30
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) (P810031/S065)Johnson & Johnson Surgical Vision, Inc.2019-04-29
Lotrafilcon A Soft Contact Lenses; Lotrafilcon B Soft Contact Lenses (P010019/S069)Alcon Laboratories, Inc.2019-04-24
PMMA Single-Piece Anterior Chamber Intraocular Lenses (P880087/S028)Alcon Laboratories2019-04-22
AcrySof Posterior Chamber Intraocular Lenses (P930014/S122)Alcon Laboratories, Inc.2019-04-22
PMMA Single-Piece Posterior Chamber Intraocular Lens (P840060/S045)Alcon Laboratories2019-04-22
AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (P040020/S090)Alcon Research, Ltd.2019-04-22
AcrySof® IQ ReSTOR® Posterior Chamber Intraocular Lenses (P040020/S089)Alcon Research, Ltd.2019-04-22
AcrySof® Posterior Chamber Intraocular Lens (P930014/S121)Alcon Laboratories, Inc.2019-04-22
PMMA Single-Piece Posterior Chamber Intraocular Lenses (P840060/S046)Alcon Laboratories2019-04-22
PMMA Multi-Piece Posterior Chamber Intraocular Lens (P810032/S068)Alcon Laboratories2019-04-22
PMMA Multi-Piece Posterior Chamber Intraocular Lenses (P810032/S069)Alcon Laboratories2019-04-22
PMMA Single-Piece Anterior Chamber Intraocular Lens (P880087/S027)Alcon Laboratories2019-04-22
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S002)Glaukos Corporation2019-04-16
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) (P170043/S001)Glaukos Corporation2019-04-16
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S106)Vistakon, Division of Johnson & Johnson Vision Car2019-04-16
Visian ICL (Implantable Collamer Lens) (P030016/S036)STAAR Surgical Company2019-04-15
Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses (P060011/S015)Rayner Intraocular Lenses , Ltd.2019-04-12
C-flex Intraocular, C-flex Aspheric Intraocular, Aspheric Intraocular and RayOne Aspheric Lens (P060011/S017)Rayner Intraocular Lenses , Ltd.2019-04-12
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P990010/S008)Amo Manufacturing USA, LLC2019-04-12
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P910062/S008)Amo Manufacturing USA, LLC2019-04-12
STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System (P930016/S056)Amo Manufacturing USA, LLC2019-04-12
Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear; Euclid Systems ORthokeratology (tisilfoc (P040029/S007)Euclid Vision Corporation2019-04-11
Biofinity XR Toric Lenses (P080011/S091)CooperVision, Inc.2019-04-09
RxSight Light Adjustable Lens (LAL) and light Delivery Device (LDD) (P160055/S004)Rxsight, Inc.2019-04-05
TECNIS CL Foldable Silicone Intraocular Lens (P880081/S042)Johnson & Johnson Surgical Vision, Inc.2019-04-05
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S102)Vistakon, Johnson & Johnson Vision Products, Inc.2019-04-05
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S105)Vistakon, Division of Johnson & Johnson Vision Car2019-04-05
TECNIS 3-Piece Acrylic Monofocal (P990080/S050)Johnson & Johnson Surgical Vision, Inc.2019-04-01
SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS 1-Piece OptiBlue IOL, Preloaded TECNIS 1-Piece IOL, TECNIS Multifocal 1-P (P980040/S102)Johnson & Johnson Surgical Vision, Inc.2019-04-01
C-flex Intraocular Lens, C-flex Aspheric Intraocular Lens, 6.0mm Aspheric Intraocular Lens adn RayOne Aspheric (P060011/S016)Rayner Intraocular Lenses , Ltd.2019-03-28
Capsular Tension Ring (CTR) (P030023/S007)Ophtec BV2019-03-27
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S037)The Cooper Companies2019-03-26
Implantable Miniature Telescope (IMT) (P050034/S020)Samsara Vision, Inc.2019-03-22
(lotrafilcon A) Soft Contact Lenses for Daily and Extended Wear (P010019/S071)Alcon Laboratories, Inc.2019-03-22
Ophthalmic Viscosurgical Devices (P840064/S070)Alcon Laboratories2019-03-20
AcrySof Intraocular Lenses (P930014/S119)Alcon Laboratories, Inc.2019-03-14
ALLEGRO Topolyzer VARIO and Patient Bed Swivel (P020050/S032)Alcon Laboratories, Inc.2019-03-14
TECNIS 3-Piece Multifocal (P080010/S018)Johnson & Johnson Surgical Vision, Inc.2019-03-14
TECNIS 3-Piece Acrylic Monofocal (P990080/S049)Johnson & Johnson Surgical Vision, Inc.2019-03-14
SENSAR and TECNIS 1-Piece IOL, TECNIS OpticBlue IOL, TECNIS Multifocal 1-Piece IOL, TECNIS Symfony Extended Range of Vis (P980040/S101)Johnson & Johnson Surgical Vision, Inc.2019-03-14
WaveLight Analyzer II, ALLEGRO Topolyzer VARIO, Patient Bed Swivel (P030008/S028)Alcon Laboratories, Inc.2019-03-14
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S036)The Cooper Companies2019-03-12
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S079)CooperVision, Inc.2019-03-08
ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses (P890023/S035)The Cooper Companies2019-03-08
methafilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P850079/S080)CooperVision, Inc.2019-03-08
Visian Toric ICL (IMPLANTABLE COLLAMER LENS) (P030016/S034)STAAR Surgical Company2019-03-07
Light Adjustable Lens (LAL) and Light Delivery Device (LDD) (P160055/S003)Rxsight, Inc.2019-03-06
RxSight Light Adjustable Lens (LAL) and Light Delivery Device (P160055/S002)Rxsight, Inc.2019-03-04
SofPort Posterior Chamber Intraocular Lenses (P910061/S025)Bausch & Lomb2019-02-28
PMMA Posterior Chamber Intraocular Lenses (P840039/S063)Bausch & Lomb, Inc.2019-02-28
PMMA Anterior Chamber Intraocular Lenses (P880090/S030)Bausch & Lomb, Inc.2019-02-28
comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses (P080011/S090)CooperVision, Inc.2019-02-26
Biofinity toric (P080011/S089)CooperVision, Inc.2019-02-21
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Every clearance here is in the API, with alerts when new ones post.