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Ophthalmic

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

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RecordFirmDate
ACRYSOF ASPHERIC UV-ABSORBING RESTOR +2.5 INRAOCULAR LENS & ACRTSOF ASPHERIC UV-ABSORBING RESTOR +3.0 INTRAOCULAR LENS (P040020/S066)Alcon Research, Ltd.2017-03-02
VISTAKON Brand Contact Lenses (N18033/S088)Vistakon, Johnson & Johnson Vision Products, Inc.2017-03-01
VISUMAX FEMTOSECOND LASER SYSTEM (P150040/S001)Carl Zeiss Meditec, Inc.2017-02-28
METHAFILCON A AND METHAFILCON B SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P850079/S073)CooperVision, Inc.2017-02-28
POLYMACON SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P780007/S056)CooperVision, Inc.2017-02-28
OCUFILCON D SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P890023/S027)The Cooper Companies2017-02-28
CONFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S055)CooperVision, Inc.2017-02-27
VISTAKON® (etafilcon A) Brand Contact Lenses (N18033/S087)Vistakon, Johnson & Johnson Vision Products, Inc.2017-02-22
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S068)Vistakon, Division of Johnson & Johnson Vision Car2017-02-22
AMVISC & AMVISC PLUS OVD (P810025/S038)Bausch & Lomb, Inc.2017-02-17
OcuCoat OVD (P860047/S033)Bausch & Lomb, Inc.2017-02-17
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S067)Vistakon, Division of Johnson & Johnson Vision Car2017-02-17
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S066)Vistakon, Division of Johnson & Johnson Vision Car2017-02-14
ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE LOADED DELIVERY SYSTEM MODELS (P930014/S097)Alcon Laboratories, Inc.2017-02-14
METHAFILCON A SOFT HYDROPHILIC EXTENDED WEAR CONTACT LENSES (P850079/S072)CooperVision, Inc.2017-02-13
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S065)Vistakon, Division of Johnson & Johnson Vision Car2017-02-08
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S086)Vistakon, Johnson & Johnson Vision Products, Inc.2017-02-08
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S031)Lenstec, Inc.2017-02-07
POLYMACON SOFT (HYDROPHILIC) CONTACT LENSES (P780007/S055)CooperVision, Inc.2017-02-03
COMFILCON A SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S053)CooperVision, Inc.2017-02-03
OCUFILCON D SOFT ( HYDROPHILIC) CONTACT LENSES (P890023/S026)The Cooper Companies2017-02-03
BIOFINITY SPHERE AND BIOFINITY XR SPHERE (P080011/S054)CooperVision, Inc.2017-02-02
FortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C (P010059/S006)Morcher GmbH2017-01-26
VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA (P030016/S030)STAAR Surgical Company2017-01-25
HYDRASOFT CONTACT LENS (P850079/S071)CooperVision, Inc.2017-01-17
AcrySof IQ Aspheric IOL with the UltraSert Pre-loaded Delivery System (P930014/S096)Alcon Laboratories, Inc.2017-01-13
VISTAKON (SENOFILCON A) BRANDED CONTACT LENSES. (P040045/S064)Vistakon, Division of Johnson & Johnson Vision Car2017-01-12
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S085)Vistakon, Johnson & Johnson Vision Products, Inc.2017-01-12
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S030)Lenstec, Inc.2017-01-11
STAR EXCIMER LASER SYSTEM (P930016/S049)Amo Manufacturing USA, LLC2017-01-11
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S063)Vistakon, Division of Johnson & Johnson Vision Car2017-01-10
BIOFINITY XR Toric (P080011/S052)CooperVision, Inc.2016-12-29
REVISION OPTICS RAINDROP NEAR VISION INLAY (P150034/S001)Rvo 2.0, Inc. (D.B.A. Optics Medical)2016-12-27
SofLens (polymacon) Visibility Tinted Contact Lens (N16895/S099)Bausch & Lomb, Inc.2016-12-27
ACRYSOF IQ RESTOR +3.0 D MULTIFOCAL TORIC INTRAOCULAR LENS (P040020/S049)Alcon Research, Ltd.2016-12-22
IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S016)Samsara Vision, Inc.2016-12-20
SINGLE PIECE POSTERIOR CHAMBER (P840060/S044)Alcon Laboratories2016-12-15
VISTAKON (SENOFILCON A) CONTACT LENS, (P040045/S062)Vistakon, Division of Johnson & Johnson Vision Car2016-12-15
SINGLE PIECE ANTERIOR CHAMBER IOL (P880087/S026)Alcon Laboratories2016-12-15
ACRYSOF (R) POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P930014/S098)Alcon Laboratories, Inc.2016-12-15
MULTI-PIECE POSTERIOR CHAMBER (P810032/S067)Alcon Laboratories2016-12-15
ACRYSOF RESTOR POSTERIOR CHAMBER IOL (P040020/S065)Alcon Research, Ltd.2016-12-15
HEALON DUET DUAL PACK (P810031/S061)Johnson & Johnson Surgical Vision, Inc.2016-12-12
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD) (3% SODIUM HYALURONATE) (P110007/S011)Johnson & Johnson Surgical Vision, Inc.2016-12-12
GLAUKOS ISTENT TRABECULAR MICRO BYPASS STENT SYSTEM (P080030/S019)Glaukos Corporation2016-12-05
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S076)Johnson & Johnson Surgical Vision, Inc.2016-12-05
BIOFINITY COMFILCON A SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES (P080011/S051)CooperVision, Inc.2016-11-23
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S084)Vistakon, Johnson & Johnson Vision Products, Inc.2016-11-22
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S061)Vistakon, Division of Johnson & Johnson Vision Car2016-11-22
CEEON EDGE FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL 911A (P990080/S044)Johnson & Johnson Surgical Vision, Inc.2016-11-21
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S075)Johnson & Johnson Surgical Vision, Inc.2016-11-21
WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P020050/S023)Alcon Laboratories, Inc.2016-11-21
SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S067)Johnson & Johnson Surgical Vision, Inc.2016-11-18
CyPass Stent (P150037/S003)Alcon Research, Ltd.2016-11-17
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S063)Alcon Laboratories2016-11-17
IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM (P930016/S045)Amo Manufacturing USA, LLC2016-11-14
BIOFINITY ENERGYS (P080011/S050)CooperVision, Inc.2016-11-03
CyPass System (P150037/S001)Alcon Research, Ltd.2016-11-03
VISTAKON (SENOFILCON A) BAND CONTACT LENS, (P040045/S060)Vistakon, Division of Johnson & Johnson Vision Car2016-10-27
VISTAKON SENOFILCON A BRAND CONTACT LENSES (P040045/S059)Vistakon, Division of Johnson & Johnson Vision Car2016-10-20
SOFTEC HD,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO (P090022/S025)Lenstec, Inc.2016-10-20
IMPLANTABLE MINIATURE TELESCOPE (IMT) (P050034/S017)Samsara Vision, Inc.2016-10-20
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S058)Vistakon, Division of Johnson & Johnson Vision Car2016-10-12
AcrySof® IQ Aspheric IOL with the UltraSertTM Pre-loaded Delivery System AU00T0 (P930014/S092)Alcon Laboratories, Inc.2016-10-12
BIOFINITY XR TORIC (P080011/S048)CooperVision, Inc.2016-10-11
BIOFINITY XR TORIC (P080011/S047)CooperVision, Inc.2016-10-11
KAMRA INLAY (P120023/S002)Corneagen2016-10-07
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% Sodium Hyaluronate) (P110007/S008)Johnson & Johnson Surgical Vision, Inc.2016-10-07
Healon Ultimate Dual Pack, HEALON, HEALON GV, HEALON5, and Healon Duet Dual Pack products (P810031/S058)Johnson & Johnson Surgical Vision, Inc.2016-10-07
VISTAKON (senofilcon A) Brand Contact Lenses (P040045/S057)Vistakon, Division of Johnson & Johnson Vision Car2016-10-07
BIOFINITY ENERGY ASPHERE (P080011/S046)CooperVision, Inc.2016-10-05
TECNIS 1-Piece Multifocal IOLs; TECNIS Symfony Extended Range of Vision (EVR) IOL., TECNIS Symfony Toric ERV IOLs (P980040/S074)Johnson & Johnson Surgical Vision, Inc.2016-10-04
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S018)Glaukos Corporation2016-09-30
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S029)Lenstec, Inc.2016-09-28
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S028)Lenstec, Inc.2016-09-22
Sofmed Toric Weeklies (P890023/S025)The Cooper Companies2016-09-22
TECNIS 1-Piece IOL; OptiBlue; Multifocal; Toric 1-Piece IOLs; TECNIS i Tee Preloaded Delivery System; Symfont Extended R (P980040/S073)Johnson & Johnson Surgical Vision, Inc.2016-09-16
VISUMAX FEMTOSECOND LASER (P150040)Carl Zeiss Meditec, Inc.2016-09-13
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S016)Alcon Laboratories2016-09-09
LOTRAFILCON A AND B SOFT CONTACT LENSES FOR DAILY AND EXTENDED WEAR (P010019/S052)Alcon Laboratories, Inc.2016-09-08
C-FLEX MODEL 570C, C-Flex Aspheric 970C and 600 C Aspheric INTRAOCULAR LENS (IOL) (P060011/S010)Rayner Intraocular Lenses , Ltd.2016-08-19
TECNIS TORIC CALCULATOR (P980040/S066)Johnson & Johnson Surgical Vision, Inc.2016-08-16
SOFLENS (POLYMACON) VISIBILITY TINTED CONTACT LENSES (N16895/S098)Bausch & Lomb, Inc.2016-08-12
ACRYSOF INTRAOCULAR LENSES (P930014/S093)Alcon Laboratories, Inc.2016-08-12
Single-Piece Anterior Chamber IOL (P880087/S025)Alcon Laboratories2016-08-11
Multi-Piece Posterior Chamber IOL (P810032/S066)Alcon Laboratories2016-08-11
ACRYSOF Posterior Chamber Intraocular Lens with UltraSert Preloaded Delivery System (P930014/S095)Alcon Laboratories, Inc.2016-08-11
Single-Piece Posterior Chamber IOL (P840060/S043)Alcon Laboratories2016-08-11
VISTAKON(etafilcon A) brand contact lenses (N18033/S082)Vistakon, Johnson & Johnson Vision Products, Inc.2016-08-10
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S083)Vistakon, Johnson & Johnson Vision Products, Inc.2016-08-08
ACRYSOF IQ TORIC IOL WITH THE ULTRASERT PRE-LOADED DELIVERY SYSTEM (P930014/S091)Alcon Laboratories, Inc.2016-08-05
SENSAR SOFT ACRYLIC INTRAOCULAR LENS (P980040/S071)Johnson & Johnson Surgical Vision, Inc.2016-07-29
TECNIS CL FOLDABLE SILICONE INTRAOCULAR LENS (P880081/S040)Johnson & Johnson Surgical Vision, Inc.2016-07-29
TECNIS ACRYLIC INTRAOCULAR LENS (P990080/S043)Johnson & Johnson Surgical Vision, Inc.2016-07-29
CyPass Micro-Stent (P150037)Alcon Research, Ltd.2016-07-29
CRYSTALENS ACCOMMODATING INTRAOCULAR LENS & TRULIGN TORIC INTRAOCULAR LENS (P030002/S038)Bausch & Lomb, Inc.2016-07-27
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (P990023/S015)Alcon Laboratories2016-07-26
BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P860022/S059)Bausch & Lomb2016-07-25
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR AND VISION SHAPING TREATMENT (P010062/S010)Bausch & Lomb2016-07-25
RESURE SEALANT (P130004/S002)Ocular Therapeutix, Inc.2016-07-21
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