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Ophthalmic

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

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RecordFirmDate
MULTI-PIECE PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS) (P810032/S053)Alcon Laboratories2007-02-09
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS (P010062/S005)Bausch & Lomb2007-02-01
ACRYSOF RESTOR APODIZED DIFFRACTIVE ASPHERIC IOL MODELS SN6AD3 AND MN6AD3 (P040020/S003)Alcon Research, Ltd.2007-01-30
AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S009)Johnson & Johnson Surgical Vision, Inc.2007-01-16
AMO SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (P980040/S010)Johnson & Johnson Surgical Vision, Inc.2007-01-16
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIORCHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A & 913A, TECNIS Z9000 & Z9001 (P990080/S014)Johnson & Johnson Surgical Vision, Inc.2007-01-16
ARRAY MULTIFOCAL FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER IOL, CEEON 911A & 913A, TECNIS Z9000 & Z9001 (P990080/S013)Johnson & Johnson Surgical Vision, Inc.2007-01-16
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A ,913A & TECNIS Z9000, Z9001 (P990080/S015)Johnson & Johnson Surgical Vision, Inc.2007-01-16
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON 911A,913A & TECNIS Z9000 & Z9001 (P990080/S016)Johnson & Johnson Surgical Vision, Inc.2007-01-16
FOLDABLE ULTAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A,913A 7 TECNIS Z9000,Z9001 (P990080/S018)Johnson & Johnson Surgical Vision, Inc.2007-01-16
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES(IOLS), CEEON 911A, 913A & TECNIS Z9000,Z9001 (P990080/S017)Johnson & Johnson Surgical Vision, Inc.2007-01-16
TECNIS FOLDABLE ACRYLIC POSTERIOR CHAMBER INTRAOCULAR LENS (IOL), MODEL AR40XEM (P980040/S007)Johnson & Johnson Surgical Vision, Inc.2007-01-04
OCUCOAT (P860047/S019)Bausch & Lomb, Inc.2006-12-21
BD 1% OVD (P960011/S012)Altacor , Ltd.2006-12-19
O2 OPTIX (LOTRAFILCON B) SOFT CONTACT LENSES (P010019/S005)Alcon Laboratories, Inc.2006-12-19
LI61AO LENS (P910061/S015)Bausch & Lomb2006-12-06
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES ? HEALON, HEALON GV, AND HEALON5 (P810031/S032)Johnson & Johnson Surgical Vision, Inc.2006-12-01
PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY (P050031)CooperVision, Inc.2006-11-16
NIDEK EC-5000 EXCIMER LASER (P970053/S010)Nidek Co., Ltd.2006-11-08
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES, CEEON MODELS 911A & 913A, TECNIS MODELS Z9000 (P990080/S010)Johnson & Johnson Surgical Vision, Inc.2006-11-08
FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000 (P990080/S011)Johnson & Johnson Surgical Vision, Inc.2006-11-08
FOLDABLE ULTRAVIOLET LIGHT ABSORING POSTERIOR CHAMBER INTRACOCULAR LENSES (IOLS) CEEON MODELS 911A AND 913A AND TECNIS (P990080/S012)Johnson & Johnson Surgical Vision, Inc.2006-11-06
VISX STAR S4 IR EXCIMER LASER SYSTEM AND WAVESCAN SYSTEM (P930016/S026)Amo Manufacturing USA, LLC2006-11-03
LADARVISION 4000 AND LADAR6000 EXCIMER LASER SYSTEMS AND THE CUSTOMCORNEA SURGERY PLANNING SOFTWARE (P970043/S026)Alcon Laboratories2006-11-01
VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND TINTED (VISIBILITY AND/OR COSMETICALLY) W/UV BLOCKER (N18033/S040)Vistakon, Johnson & Johnson Vision Products, Inc.2006-10-31
ARRAY MULTIFOCAL UV-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S015)Johnson & Johnson Surgical Vision, Inc.2006-10-20
ARRAY MULTIFOCAL INTRAOCULAR LENSES (P990080/S009)Johnson & Johnson Surgical Vision, Inc.2006-10-18
AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (P980040/S008)Johnson & Johnson Surgical Vision, Inc.2006-10-18
CEEON INTRAOCULAR LENSES (P960028/S016)Johnson & Johnson Surgical Vision, Inc.2006-10-18
NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S009)Nidek Co., Ltd.2006-10-11
PUREVISION, PUREVISION TORIC AND PUREVISION MULTI-FOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S010)Bausch & Lomb, Inc.2006-09-22
LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR (P010019/S004)Alcon Laboratories, Inc.2006-09-20
VIFILCON A SOFT CONTACT LENSES FOR EXTENDED WEAR (P820021/S031)Alcon Laboratories, Inc.2006-09-20
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S028)Johnson & Johnson Surgical Vision, Inc.2006-09-14
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S029)Johnson & Johnson Surgical Vision, Inc.2006-09-13
SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S030)Johnson & Johnson Surgical Vision, Inc.2006-09-13
HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (P810031/S027)Johnson & Johnson Surgical Vision, Inc.2006-08-28
ACRYSOF INTRAOCULAR LENSES (IOLS) (P930014/S018)Alcon Laboratories, Inc.2006-08-24
PMMA ANTERIOR CHAMBER IOLS (P880087/S012)Alcon Laboratories2006-08-24
AMVISC & AMVISC PLUS (P810025/S026)Bausch & Lomb, Inc.2006-08-24
PMMA MULTI-PIECE POSTERIOR CHAMBER VS100 IOLS (P810032/S052)Alcon Laboratories2006-08-24
PMMA SINGLE-PIECE POSTERIOR CHAMBER IOLS (P840060/S030)Alcon Laboratories2006-08-24
ACRYSOF RESTOR APODIZED DIFFRACTIVE IOLS (P040020/S002)Alcon Research, Ltd.2006-08-24
STAARVISC II AND SHELLGEL SODIUM HYALURONATE (P000046/S014)Anika Therapeutics, Inc.2006-08-24
MEL 80 EXCIMER LASER SYSTEM (P060004)Carl Zeiss Meditec, Inc.2006-08-11
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P020050/S004)Alcon Laboratories, Inc.2006-07-26
LI61AOV (ADVANCED OPTICS VIOLET-SHIELD) LENS (P910061/S013)Bausch & Lomb2006-07-20
TECNIS CL FOLDABLE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL Z9002) (P880081/S032)Johnson & Johnson Surgical Vision, Inc.2006-07-20
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM (P970043/S025)Alcon Laboratories2006-07-05
ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM (P030008/S003)Alcon Laboratories, Inc.2006-06-16
VISCOAT, DUOVISC AND DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES (P840064/S031)Alcon Laboratories2006-06-16
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S018)Alcon Research, Ltd.2006-06-16
ALLEGRETTO WAVE EYE-Q LASER SYSTEM (P020050/S003)Alcon Laboratories, Inc.2006-06-16
BOSTON EQUALENS (ITAFLUOROFOCON A AND OPRIFOCON A) (P860022/S056)Bausch & Lomb2006-05-30
RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY) (P010062/S004)Bausch & Lomb2006-05-30
VISX STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S024)Amo Manufacturing USA, LLC2006-05-03
LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM (P970043/S022)Alcon Laboratories2006-05-02
LADAR 6000 EXCIMER LASER SYSTEM (P970043/S023)Alcon Laboratories2006-05-01
LADAR 6000 EXCIMER LASER SYSTEM (P970043/S019)Alcon Laboratories2006-05-01
LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S020)Alcon Laboratories2006-05-01
ULTRAVIOLET (UV) ABSORBING AND NON-UV ABSORBING POLYMETHYLMETHACRYLATE (PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES (IOL) (P840039/S055)Bausch & Lomb, Inc.2006-04-24
WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM (P030008/S004)Alcon Laboratories, Inc.2006-04-19
VIEWPOINT CK SYSTEM (P010018/S009)Refractec, Inc.2006-04-06
QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS (P050026)Bausch + Lomb Ireland Limited2006-04-04
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION (P990027/S007)Technolas Perfect Vision GmbH2006-03-15
AMVISC AND AMVISC PLUS (P810025/S025)Bausch & Lomb, Inc.2006-03-14
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (P030002/S006)Bausch & Lomb, Inc.2006-03-03
ADATO SIL OL 5000 SILICONE OIL (P910071/S008)Bausch & Lomb2006-02-24
BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR (P010062/S003)Bausch & Lomb2006-02-21
STAARVISC II, SHELLGEL AND COEASE (P000046/S013)Anika Therapeutics, Inc.2006-01-24
VISIAN ICL (IMPLANTABLE COLLAMER LENS) (P030016)STAAR Surgical Company2005-12-22
DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S030)Alcon Laboratories2005-12-21
ARRAY MULTIFOCAL POSTERIOR CHAMBER INTRAOCULAR LENS (P960028/S013)Johnson & Johnson Surgical Vision, Inc.2005-12-21
VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (P040045)Vistakon, Division of Johnson & Johnson Vision Car2005-12-20
ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S) (P910071/S007)Bausch & Lomb2005-12-16
ACRYSOF TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5 (P930014/S016)Alcon Laboratories, Inc.2005-12-16
INTACS PRESCRIPTION INSERTS (P980031/S009)Addition Technology2005-11-23
ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER IOL (P880091/S019)Staar Surgical Co.2005-10-19
ALCON LADARVISION 4000 EXCIMER LASER SYSTEM- (P970043/S021)Alcon Laboratories2005-10-14
CIONNI CAPSULAR TENSION RINGS (P010059/S002)Morcher GmbH2005-10-14
JSZ ORTHOKERATOLOGY CONTACT LENSES FOR OVERNIGHT WEAR (P040029/S001)Euclid Vision Corporation2005-10-14
VIEWPOINT CK SYSTEM (P010018/S008)Refractec, Inc.2005-09-30
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S023)Amo Manufacturing USA, LLC2005-09-28
STAARVISC II SODIUM HYALURONATE (P000046/S012)Anika Therapeutics, Inc.2005-09-26
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL) (P030002/S005)Bausch & Lomb, Inc.2005-09-26
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S029)Alcon Laboratories2005-09-21
BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY (P960011/S010)Altacor , Ltd.2005-09-15
ACRYSOF TORIC POSTERIOR CHAMBER INTRAOCULAR LENS MODELS SA60T3, SA60T4 AND SA60T5 (P930014/S015)Alcon Laboratories, Inc.2005-09-14
CRYSTALENS SE, MODEL AT-45 SE (P030002/S004)Bausch & Lomb, Inc.2005-09-08
STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM (P930016/S021)Amo Manufacturing USA, LLC2005-08-30
AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS (P880081/S031)Johnson & Johnson Surgical Vision, Inc.2005-08-04
AMO SILICONE MONOFOCAL AND MULTIFOCAL INTRAOCULAR LENS (P960028/S014)Johnson & Johnson Surgical Vision, Inc.2005-08-04
SHELLGEL SODIUM HYALURONATE (P000046/S011)Anika Therapeutics, Inc.2005-08-03
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE, PROVISC PACKAGED IN DUOVISC VISCOELASTIC SYSTEM AND DISCOVISC OPHTHALMIC VISCO (P840064/S028)Alcon Laboratories2005-07-29
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S017)Alcon Research, Ltd.2005-07-29
ACRYSOF RESTOR NATURAL IOL MODELS SN60D3 AND MN60D3 (P040020/S001)Alcon Research, Ltd.2005-07-29
ELASTIC LENS SINGLE-PIECE SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS (P880091/S018)Staar Surgical Co.2005-06-28
COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)... (P850079/S042)CooperVision, Inc.2005-06-14
CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL) (P030002/S003)Bausch & Lomb, Inc.2005-06-06
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES-THERAPEUTIC USE (P980006/S007)Bausch & Lomb, Inc.2005-05-27
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