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Ophthalmic

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

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RecordFirmDate
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P870013/S016)Bausch & Lomb2003-08-13
PMMA POSTERIOR CHAMBER IOL (P790027/S069)Bausch & Lomb2003-08-13
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P880090/S018)Bausch & Lomb, Inc.2003-08-13
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P840039/S051)Bausch & Lomb, Inc.2003-08-13
SILICONE INTRAOCULAR LENSES (P910058/S012)Bausch & Lomb, Inc.2003-08-13
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P870073/S017)Bausch & Lomb, Inc.2003-08-13
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P850059/S024)Bausch & Lomb Surgical, Inc.2003-08-13
POLYMETHYLMETHA-CRYLATE (PMMA) INTRAOCULAR LENSES (IOLS) (P860002/S018)Bausch & Lomb2003-08-13
HYDROVIEW IOLS (P990014/S003)Bausch & Lomb, Inc.2003-08-13
VIEWPOINT CK SYSTEM (P010018/S004)Refractec, Inc.2003-07-31
PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV (P880090/S019)Bausch & Lomb, Inc.2003-07-23
BIOBURDEN TESTING (P840039/S052)Bausch & Lomb, Inc.2003-07-23
BIOBURDEN TESTING (P910061/S010)Bausch & Lomb2003-07-23
LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S013)Alcon Laboratories2003-07-16
ACRYSOF NATURAL SINGLE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS (MODEL SB30AL) (P930014/S009)Alcon Laboratories, Inc.2003-06-24
VIEWPOINT CK SYSTEM (P010018/S002)Refractec, Inc.2003-06-09
OCUCOAT (P860047/S014)Bausch & Lomb, Inc.2003-06-06
INTACS PRESCRIPTION INSERTS (P980031/S005)Addition Technology2003-05-30
VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE (P840064/S024)Alcon Laboratories2003-05-23
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S015)Alcon Research, Ltd.2003-05-23
STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM (P930016/S016)Amo Manufacturing USA, LLC2003-05-23
STAARVISC II, SHELLGEL AND COEASE (P000046/S008)Anika Therapeutics, Inc.2003-05-22
OCUCOAT(2%HYDROXYPROPYLMETHLCELLULOSE SOLUTION) (P860047/S013)Bausch & Lomb, Inc.2003-05-08
OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION) (P860047/S012)Bausch & Lomb, Inc.2003-04-16
SOFTLENS66 TORIC (ALPHAFILCON A)VISIBILITY TINTED CONTACT LENSES (P960022/S003)Bausch & Lomb, Inc.2003-04-04
PERFLUORON (P950018/S009)Alcon Laboratories2003-03-20
NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS (P010019/S002)Alcon Laboratories, Inc.2003-03-19
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS (P000046/S006)Anika Therapeutics, Inc.2003-03-18
STAARVISC II, SHELLGEL AND COEASE SODIUM HYALURONATE VISCOELASTICS (P000046/S007)Anika Therapeutics, Inc.2003-03-12
FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL (P830037/S048)Alcon Laboratories, Inc.2003-03-06
TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S004)Technolas Perfect Vision GmbH2003-02-25
METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR (P850079/S041)CooperVision, Inc.2003-02-12
SILICONE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (P990080/S003)Johnson & Johnson Surgical Vision, Inc.2003-02-04
PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES (P790027/S068)Bausch & Lomb2003-01-27
ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER (N18033/S038)Vistakon, Johnson & Johnson Vision Products, Inc.2003-01-08
ADATO SIL-OL 5000 SILICONE OIL SYRINGE (P910071/S006)Bausch & Lomb2002-12-23
LSX EXCIMER LASER SYSTEM (P980008/S012)Lasersight Technologies, Inc.2002-12-16
PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY (P900066/S006)Airgas Therapeutics, LLC2002-12-10
MENICON SF-P (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS (P880098/S012)Menicon Co, Ltd.2002-12-10
STAARVISC II,SHELLGEL AND COEASE VISCOELASTICS (P000046/S004)Anika Therapeutics, Inc.2002-12-03
AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS (P810025/S021)Bausch & Lomb, Inc.2002-12-03
FRESHLOOK RADIANCE SPHERICAL AND TORIC (PHEMFILCON A) SOFT CONTACT LENSES (P830037/S047)Alcon Laboratories, Inc.2002-11-26
LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S011)Alcon Laboratories2002-11-07
MENICON Z (P990018/S003)Menicon Co, Ltd.2002-11-06
BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY) (P960011/S007)Altacor , Ltd.2002-11-01
NIDEK EC-5000 EXCIMER LASER SYSTEM (P970053/S007)Nidek Co., Ltd.2002-10-28
VIEWPOINT CK SYSTEM (KERATOPLAST TIP COMPONENT) (P010018/S001)Refractec, Inc.2002-10-28
LADARVISION 4000 EXCIMER LASER SYSTEM (P970043/S010)Alcon Laboratories2002-10-18
ACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE (P930014/S010)Alcon Laboratories, Inc.2002-10-07
SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS, MODEL Z9000 (P990080/S002)Johnson & Johnson Surgical Vision, Inc.2002-09-24
PHEMFILCON A (P830037/S046)Alcon Laboratories, Inc.2002-09-04
HYDROVIEW IOL BLANK MATERIAL (P990014/S002)Bausch & Lomb, Inc.2002-09-04
STAARVISC II SODIUM HYALURONATE AND SHELLGEL SODIUM HYALURONATE (P000046/S002)Anika Therapeutics, Inc.2002-08-30
VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM (P930016/S015)Amo Manufacturing USA, LLC2002-08-07
PERFLUORON (P950018/S008)Alcon Laboratories2002-07-29
CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS (P960036/S007)Ioltech, S.A.2002-07-26
HEALON SODIUM HYALURONATE (P810031/S024)Johnson & Johnson Surgical Vision, Inc.2002-07-25
AMVISC/AMVISC PLUS SODIUM HYALURONATE (P810025/S020)Bausch & Lomb, Inc.2002-07-19
MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR (P990018/S002)Menicon Co, Ltd.2002-07-12
FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES (P010019/S001)Alcon Laboratories, Inc.2002-07-05
BAUSCH AND LOMB HEFILCON A, B AND C HYDROPHILIC CONTACT LENSES (N17676/S028)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB ELASTOFILCON A HYDROPHILIC CONTACT LENSES (P850068/S008)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB LIDOFILCON A AND B HYDROPHILIC CONTACT LENSES (P880029/S015)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB POLYMACON HYDROPHILIC CONTACT LENSES (N16895/S088)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES (P960022/S002)Bausch & Lomb, Inc.2002-06-28
BAUSCH AND LOMB BALAFILCON A HYDROPHILIC CONTACT LENSES (P980006/S003)Bausch & Lomb, Inc.2002-06-28
CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS (P960036/S006)Ioltech, S.A.2002-06-20
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC CONTACT LENS) (P850079/S040)CooperVision, Inc.2002-06-13
PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100.. (P870024/S043)CooperVision, Inc.2002-06-13
MEMORYLENS MODEL U940A UV-ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL (P960036/S005)Ioltech, S.A.2002-05-23
PMMA INTRAOCULAR LENS (P790027/S067)Bausch & Lomb2002-05-21
PMMA INTAOCULAR LENS (P840039/S050)Bausch & Lomb, Inc.2002-05-21
TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S002)Technolas Perfect Vision GmbH2002-05-17
HYPERION LTK SYSTEM (P990078/S005)Sunrise Technologies, Inc.2002-05-08
COEASE SODIUM HYALURONATE (P000046/S003)Anika Therapeutics, Inc.2002-05-08
BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS (P860022/S054)Bausch & Lomb2002-05-06
ALLERGAN SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL (P980040/S003)Johnson & Johnson Surgical Vision, Inc.2002-05-01
FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/ (P830037/S045)Alcon Laboratories, Inc.2002-05-01
ARRAY MULTIFOCAL ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL (P960028/S007)Johnson & Johnson Surgical Vision, Inc.2002-05-01
ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S (P880081/S027)Johnson & Johnson Surgical Vision, Inc.2002-05-01
VIEWPOINT(TM) CK SYSTEM (P010018)Refractec, Inc.2002-04-11
BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY) (P960011/S008)Altacor , Ltd.2002-04-01
VISCOAT ORPHTHALMIC VISCOSURGICAL DEVICE (P840064/S023)Alcon Laboratories2002-03-25
PROVISC OPHTHALMIC VISCOSURGICAL DEVICE (P890047/S014)Alcon Research, Ltd.2002-03-25
ACUVUE 2 COLOURS (TM) BRAND (ETALFILCON A) CONTACT LENS WITH UV BLOCKER (N18033/S037)Vistakon, Johnson & Johnson Vision Products, Inc.2002-03-18
TECHNOLAS 217A EXCIMER LASER SYSTEM (P990027/S005)Technolas Perfect Vision GmbH2002-03-13
BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR) (P890023/S013)The Cooper Companies2002-03-11
PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY (P900066/S005)Airgas Therapeutics, LLC2002-01-29
SULFUR HEXAFLUORIDE FOR PNEUMATIC RETINOPEXY (P900067/S003)Airgas Therapeutics, LLC2002-01-29
SILIKON 1000 (P950008/S003)Alcon2002-01-23
EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P850079/S039)CooperVision, Inc.2002-01-17
HYDRONICS 60 UV IMT CONTACT LENS FOR EXTENDED WEAR (P890023/S011)The Cooper Companies2002-01-16
SILIKON 1000 (P950008/S004)Alcon2002-01-03
SOFT-55 EW APHAKIC (VIFILCON A) SOFT(HYDROPHILIC) SPHERICAL CONTACT LENS FOR EXTENDED WEAR (P960039/S002)Unilens Corporation, USA2002-01-03
POSTERIOR CHAMBER INTRAOCULAR LENSES (P970034/S008)Aaren Scientific2001-12-31
SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR) (P820021/S030)Alcon Laboratories, Inc.2001-12-12
BOSTON EQUALENS/BOSTON EQUALENS II (P860022/S053)Bausch & Lomb2001-11-21
ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT) (P010027)Aaren Scientific2001-11-21
PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES (P980006/S004)Bausch & Lomb, Inc.2001-11-20
PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES (P780010/S022)CooperVision, Inc.2001-11-16
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