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Ophthalmic

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

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RecordFirmDate
AIR OPTIX PLUS HYDRAGLYDE; AIR OPTIX PLUS HYDRAGLYDE FOR ASTIGMATISM; AIR OPTIX PLUS HYDRAGLYDE MULTIFOCAL; AIR OPTIX PL (P010019/S050)Alcon Laboratories, Inc.2016-07-19
SILIKON 1000 (P950008/S013)Alcon2016-07-18
TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS (P980040/S065)Johnson & Johnson Surgical Vision, Inc.2016-07-15
RINGJECT (P030023/S005)Ophtec BV2016-07-06
Raindrop Near Vision Inlay (P150034)Rvo 2.0, Inc. (D.B.A. Optics Medical)2016-06-29
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON, HEALON GV, HEALON ULTIMATE DUAL PACK, AND HEALON DUET (P810031/S057)Johnson & Johnson Surgical Vision, Inc.2016-06-28
SOFPORT POSTERIOR CHAMBER INTRAOCULAR LENSES (P910061/S023)Bausch & Lomb2016-06-27
REZOOM MULTIFOCAL INTRAOCULAR LENS (P960028/S039)Johnson & Johnson Surgical Vision, Inc.2016-06-27
SENSAR SOFT ACRYLIC INTRAOCULAR LENSES, TECNIS ACRYLIC INTRAOCULAR LENS, TECNIS ITEC PRELOADED DELIVERY SYSTEM. (P980040/S070)Johnson & Johnson Surgical Vision, Inc.2016-06-27
TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) (P080010/S013)Johnson & Johnson Surgical Vision, Inc.2016-06-27
TECNIS 3-PCS MONOFOCAL LENS (P990080/S042)Johnson & Johnson Surgical Vision, Inc.2016-06-27
FOCUS NIGHT AND DAY (LOTRAFILCON A AND B) EXTENDED WEAR SOFT CONTACT LENSES (P010019/S051)Alcon Laboratories, Inc.2016-06-23
AKREOS INTRAOCULAR LENS,MODEL AO60 and MI60L (P060022/S023)Bausch & Lomb, Inc.2016-06-23
FOCUS NIGHT & DAY (LOTRAFILCON A) EXTENDED WEAR SOFT CONTACT LENSES (P000030/S003)Alcon Laboratories, Inc.2016-06-23
ENVISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS, MODEL MX60 (P910056/S023)Bausch & Lomb, Inc.2016-06-23
TECNIS 1-PIECE IOL, TECNIS 1-PIECE OPTIBLUE IOL, PRELOADED TECNIS 1-PIECE IOL, PRELOADED TECNIS 1-PIECE OPTIBLUE IOL, PR (P980040/S069)Johnson & Johnson Surgical Vision, Inc.2016-06-17
TECNIS ACRYLIC MONOFOCAL IOL (P990080/S041)Johnson & Johnson Surgical Vision, Inc.2016-06-17
PMMA ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P840039/S061)Bausch & Lomb, Inc.2016-06-15
PMMA ABSORBING ANTERIOR CHAMBER INTRAOCULAR LENSES (P880090/S029)Bausch & Lomb, Inc.2016-06-15
HEALON SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD), HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVI (P810031/S056)Johnson & Johnson Surgical Vision, Inc.2016-06-14
BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses (P080011/S044)CooperVision, Inc.2016-06-10
BIOFINITY (COMFILCON A) Soft (Hydrophilic) Contact Lenses (P080011/S045)CooperVision, Inc.2016-06-09
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL) (P060011/S009)Rayner Intraocular Lenses , Ltd.2016-06-08
ENVISTA HYDROPHOBIC INTRAOCULAR LENS (P910056/S022)Bausch & Lomb, Inc.2016-05-27
EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S003)Euclid Vision Corporation2016-05-26
CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P990023/S014)Alcon Laboratories2016-05-18
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S047)Alcon Research, Ltd.2016-05-18
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICES; DUOVISC OPTHALMIC VISCOSURGICAL DEVICES; DISCOVISC OPTHALMIC VISCOSURGICAL DEV (P840064/S061)Alcon Laboratories2016-05-18
TECNIS 1-PIECE IOL, MULTIFOCAL 1-PIECE IOL, TORIC 1-PIECE IOL WITH THE TECNIS iTEC PRELOADED DELIVERY SYSTEM (P980040/S068)Johnson & Johnson Surgical Vision, Inc.2016-05-13
GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM (P080030/S017)Glaukos Corporation2016-05-13
KAMRA INLAY (P120023/S001)Corneagen2016-05-12
VISTAKON (SENOFILCON A) CONTACT LENS (P040045/S056)Vistakon, Division of Johnson & Johnson Vision Car2016-05-06
VISTAKON (etafilcon A) Brand Contact Lenses (N18033/S081)Vistakon, Johnson & Johnson Vision Products, Inc.2016-05-06
ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S063)Alcon Research, Ltd.2016-04-28
ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S090)Alcon Laboratories, Inc.2016-04-28
BIOFINITY (COMFILCON A) (P080011/S042)CooperVision, Inc.2016-04-05
ACRYSOF (R) UV ABSORBING INTRAOCULAR LENSES (P930014/S089)Alcon Laboratories, Inc.2016-04-01
ACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL (P040020/S061)Alcon Research, Ltd.2016-04-01
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S049)Alcon Laboratories, Inc.2016-03-30
SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S026)Lenstec, Inc.2016-03-28
CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS) (P030002/S035)Bausch & Lomb, Inc.2016-03-24
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S048)Alcon Laboratories, Inc.2016-03-23
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S047)Alcon Laboratories, Inc.2016-03-23
FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P000030/S002)Alcon Laboratories, Inc.2016-03-23
BIOFINITY (COMFILCON A) (P080011/S041)CooperVision, Inc.2016-03-21
FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P000030/S001)Alcon Laboratories, Inc.2016-03-14
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S046)Alcon Laboratories, Inc.2016-03-14
AKREOS INTRAOCULAR LENS (P060022/S022)Bausch & Lomb, Inc.2016-03-11
HYDRASOFT (METHAFILCON B) CONTACT LENS (P850079/S070)CooperVision, Inc.2016-03-09
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S045)Alcon Laboratories, Inc.2016-03-09
ACUVUE CONTACT LENS (N18033/S080)Vistakon, Johnson & Johnson Vision Products, Inc.2016-03-04
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045/S055)Vistakon, Division of Johnson & Johnson Vision Car2016-03-04
SOFT-FORM 55EW; LL-55; SOFTCON EW2 (P890040/S008)Unilens Corp., USA2016-02-29
ACRYSOF MULTIFOCAL INTRAOCULAR LENS (P040020/S060)Alcon Research, Ltd.2016-02-29
LOTRAFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S044)Alcon Laboratories, Inc.2016-02-23
CELLUGEL OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (P990023/S013)Alcon Laboratories2016-02-18
TRULIGN TORIC WEB BASED TORIC CALCULATOR (P030002/S036)Bausch & Lomb, Inc.2016-02-17
LENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS (P090022/S027)Lenstec, Inc.2016-02-12
CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS (P030002/S037)Bausch & Lomb, Inc.2016-02-09
STAR EXCIMER LASER SYSTEM (P930016/S047)Amo Manufacturing USA, LLC2016-02-09
JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S002)Euclid Vision Corporation2016-01-29
VISTAKON(SENOFILCON A) BRAND CONTACT LENSES (P040045/S054)Vistakon, Division of Johnson & Johnson Vision Car2016-01-20
LOTRAFILCON A & B SOFT CONTACT LENSES (P010019/S043)Alcon Laboratories, Inc.2016-01-15
ADATO SIL-OL 5000 SILICONE OIL (P910071/S016)Bausch & Lomb2016-01-15
REZOOM 3-PC MULTIFOCAL (P960028/S038)Johnson & Johnson Surgical Vision, Inc.2016-01-12
TENIS 3-PC MONOFOCAL-ZA9003 (P990080/S040)Johnson & Johnson Surgical Vision, Inc.2016-01-12
TECNIS 3PC MULTIFOCAL (P080010/S012)Johnson & Johnson Surgical Vision, Inc.2016-01-12
SENSAR 3PC & 1PC MONOFOCAL; TECNIS 1PC MONOFOCAL, 1PC MULTIFOCAL AND 1PC TORIC MONOFOCAL, 1PC OPTIBULE & 3PC OPTIBLUE (P980040/S064)Johnson & Johnson Surgical Vision, Inc.2016-01-12
OCUFILCON D SOFT (HYDROPHILIC) CONTACT LENSES (P890023/S024)The Cooper Companies2016-01-11
STAR EXCIMER LASER SYSTEM (P930016/S046)Amo Manufacturing USA, LLC2016-01-11
ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENS (P930014/S088)Alcon Laboratories, Inc.2016-01-06
ACRYSOF RESTOR POSTERIOR CHAMBER INTRAOCULAR LENS (P040020/S059)Alcon Research, Ltd.2016-01-06
PMMA SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P840060/S041)Alcon Laboratories2016-01-06
ACRYSOF IQ RESTORE +3.0D ADD POWER INTRAOCULAR LENS (P040020/S058)Alcon Research, Ltd.2016-01-06
PMMA MULTI-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (P810032/S064)Alcon Laboratories2016-01-06
PMMA SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENS (P880087/S023)Alcon Laboratories2016-01-06
ACRYSOF INTRAOCULAR LENS (P930014/S087)Alcon Laboratories, Inc.2015-12-31
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES-HEALON, HEALON GV, HEALON5 PRODUCTS, HEALON ULTIMATE DUAL PACK, AND H (P810031/S055)Johnson & Johnson Surgical Vision, Inc.2015-12-22
HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE) (P110007/S007)Johnson & Johnson Surgical Vision, Inc.2015-12-22
PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS (P980006/S025)Bausch & Lomb, Inc.2015-12-16
TECNIS 1-PIECE IOL, TECNIS OPTIBLUE 1-PIECE, TECNIS MULTIFOCAL 1-PIECE IOL (P980040/S063)Johnson & Johnson Surgical Vision, Inc.2015-12-14
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) (P030016/S029)STAAR Surgical Company2015-12-10
VISTAKON (SENOFILCON A) BRAND CONTACT LENSES (P040045/S053)Vistakon, Division of Johnson & Johnson Vision Car2015-12-10
ACRYSOF TORIC POSTERIOR CHANBER IOL, ACRYSOF TORIC SINGLE-PIECE NATURAL IOL, ACRYSOF IQ TORIC IOL & ACRYSOF TORIC IOL (P930014/S085)Alcon Laboratories, Inc.2015-12-04
EN VISTA HYDROPHOBIC ACRYLIC INTRAOCULAR LENS (IOL) (P910056/S021)Bausch & Lomb, Inc.2015-12-04
LOTRAFILCON B SOFT CONTACT LENSES O2OPTIX, AIR OPTIX AQUA, AIR OPTIX FOR ASTIGMATISM, AIR OPTIX AQUA MULTIFOCAL. (P010019/S042)Alcon Laboratories, Inc.2015-12-03
ENVISTA HYDROPHOBIC INTRAOCULAR LENS (P910056/S019)Bausch & Lomb, Inc.2015-11-19
ACRYSOF INTRAOCULAR LENSES (P930014/S086)Alcon Laboratories, Inc.2015-11-19
VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL) (P030016/S028)STAAR Surgical Company2015-11-17
VISTAKON (SENOFILCON.A) BRAND CONTACT LENSES (P040045/S052)Vistakon, Division of Johnson & Johnson Vision Car2015-11-17
CAPSULAR TENSION RING AND STABILEYES (P030023/S004)Ophtec BV2015-11-13
FREQUENCY XCEL TORIC XR (P850079/S069)CooperVision, Inc.2015-11-12
BIOFINITY (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P080011/S040)CooperVision, Inc.2015-11-06
BIOFINITY XR TORIC (P080011/S039)CooperVision, Inc.2015-11-06
TECHNOLAS 217A EXCIMER LASER SYSTEM FOR LASER IN-SITU KERATOMILEUSIS(LASIK), TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALI (P990027/S020)Technolas Perfect Vision GmbH2015-11-05
SOFPORT/SOFLEX INTRAOCULAR LENSES (P910061/S022)Bausch & Lomb2015-11-05
SOFLENS TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS (P960022/S011)Bausch & Lomb, Inc.2015-10-19
RAYNER C-FLEX 570C, C-FLEX ASPHERIC 970C AND 600C ASPHERIC INTRAOCULAR LENSES (P060011/S007)Rayner Intraocular Lenses , Ltd.2015-10-15
ALLEGRETTO WAVE EYE-Q (P020050/S024)Alcon Laboratories, Inc.2015-10-15
VISTAKON (ETAFILCON A) BRAND CONTACT LENSES (N18033/S079)Vistakon, Johnson & Johnson Vision Products, Inc.2015-10-15
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