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Ophthalmic

4,750 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 (K994015)Surgin Surgical Instrumentation, Inc.2000-03-15
BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544)Labtician Ophthalmics, Inc.2000-03-09
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX (K000384)CooperVision, Inc.2000-03-06
BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES (K994125)Bausch & Lomb, Inc.2000-03-03
HYLASHIELD CL (K994170)Biomatrix, Inc.2000-03-02
ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994324)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER (K994318)Vistakon, Johnson & Johnson Vision Products, Inc.2000-02-23
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION (K994021)Strieter Clinical Research Laboratories, Inc.2000-02-22
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) (K993190)Surgical Instrument Systems (Sis), Ltd.2000-02-10
SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K993580)Specialty Ultravision, Inc.2000-02-02
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR (K992787)Specialty Ultravision, Inc.2000-02-02
ULTRASHAPER KERATOME (K990227)Lasersight Technologies, Inc.2000-01-31
CAUTERY GRASPER/DISSECTOR (K994019)Starion Instruments2000-01-20
AUTOMATED OPHTHALMICS SOFTIPS (K992998)Automated Ophthalmics, Inc.2000-01-10
SOLO-CARE BRAND HARD SOLUTION (K993949)Ciba Vision Corporation2000-01-05
TUBING EXTENSION SET (K993361)Hurricane Medical2000-01-04
BLADEWORKS DISPOSABLE ALK TUBING (K993591)Blade Works, Inc.1999-12-28
PARAGON LENS VIAL (K993487)Paragon Vision Sciences1999-12-22
PARAGON LENS CARRIER (K993486)Paragon Vision Sciences1999-12-22
M-PACT CORNEAL LIGHT SHIELD (K993883)M-Pact Corp.1999-12-21
DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI (K993935)Wesley Jessen Corp.1999-12-21
KEELER CRYO MASTER & PROBES (K992954)Keeler Instruments, Inc.1999-12-21
VIT ENHANCER (K992943)Medical Instrument Development Laboratories, Inc.1999-12-10
ACTIFRESH 400 LENS (K983637)Hydron , Ltd.1999-12-10
OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS (K992264)Ocular Sciences Puerto Rico, Inc.1999-11-24
METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP (K993252)CooperVision, Inc.1999-11-24
I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN (K990292)Ophthalmic Consultants, Inc.1999-11-19
COLORMAX COLOR VISION ENHANCEMENT LENSES (K984219)Color Vision Technologies, Inc.1999-11-18
CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS (K992950)Prosthetic Soft Lens Corp.1999-11-18
RICROKERATOME BLADE (K992978)Surgistar, Inc.1999-11-16
SL990, SL980, SL950 (K992836)Cso1999-11-09
KSEA DE LA PLAZA BLEPHAROPLASTY SET (K991592)KARL STORZ Endoscopy-America, Inc.1999-11-02
LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) (K991015)Lamda Polytech , Ltd.1999-11-02
EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS (K992692)Benz Research and Development Corp.1999-10-18
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS (K992028)Allergan, Inc.1999-10-07
OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (K992466)Ocu-Ease Optical Products, Inc.1999-10-04
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES (K991965)Purilens, Inc.1999-10-01
VISINE FOR CONTACTS (K991620)Pfizer, Inc.1999-09-24
MICROKERATOME, MODEL MK-2000 (K990900)Nidek, Inc.1999-09-24
MILLENIUM MICROKERATOME, MODEL IMD-001 (K992687)Industrial & Medical Design, Inc.1999-09-24
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP (K984573)Alcon Laboratories1999-09-16
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES (K991125)Sauflon Pharmaceuticals, Ltd.1999-09-14
SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS (K991995)Softchrome, Inc.1999-08-27
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY (K992589)Opti-Centre Laboratories1999-08-26
DAILIES (NELFILCON A) ONE-DAY (K992446)Ciba Vision Johns Creek Mfg.1999-08-18
CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS (K992500)Cantor & Silver , Ltd.1999-08-18
COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS (K992339)Colorsoft Laboratories Corp.1999-08-16
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM (K991284)Nidek, Inc.1999-08-06
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION (K991403)Ciba Vision Corporation1999-07-16
SCLERAL PLUGS, 19 AND 20 GAUGE (K990872)Ophthalmic Consultants, Inc.1999-07-13
AHMED GLAUCOMA VALVE IMPLANT (K991072)New World Medical, Inc.1999-07-13
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) (K984090)Specialty Ultravision, Inc.1999-07-07
ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS (K992054)Adventures IN Color Technology, Ltd.1999-07-07
OCUSYSTEM ART ADVANTAGE, MODEL 995 (K991852)Surgical Design Corp.1999-07-07
FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS (K991781)G.T. Laboratories, Inc.1999-06-29
FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C (K991780)G.T. Laboratories, Inc.1999-06-29
W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) (K992010)Westcon Contact Lens Co., Inc.1999-06-29
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES (K991000)Wesley Jessen Corp.1999-06-28
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991163)Vistakon, Johnson & Johnson Vision Products, Inc.1999-06-08
LEICA AT550 (K990869)Leica Microsystems, Inc.1999-06-07
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS (K990815)Colorsoft Laboratories Corp.1999-06-03
THERMAL CAUTERY DEVICE, FORCEPS (K990728)Starion Instruments1999-06-03
BQ/BM INTEGRATED LASER DELIVERY SYSTEM (K990665)American Laser Corp.1999-05-17
KERATOME SYSTEM, MODEL K3000 (K984537)Insight Technologies Instruments, LLC1999-05-14
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS (K991550)Wesley Jessen Corp.1999-05-14
CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR (K990011)Continental Soft Lens, Inc.1999-05-11
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K990480)Alcon Laboratories1999-05-10
DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE (K990671)Hurricane Medical1999-05-10
ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS (K984098)Adventures IN Color Technology, Ltd.1999-05-10
ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR (K991134)Vistakon, Johnson & Johnson Vision Products, Inc.1999-05-06
KERAVISION VACUUM RING SYSTEM (K984540)Keravision, Inc.1999-04-28
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K990422)Bausch & Lomb, Inc.1999-04-27
PVS BASICS (K984436)Paragon Vision Sciences1999-04-21
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA (K990757)Cantor & Silver , Ltd.1999-04-21
S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K990281)Nissel , Ltd.1999-04-16
OXYCON LENS (K990895)Concise Contact Lens Co.1999-04-14
LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (K990224)Labtician Ophthalmics, Inc.1999-04-12
DI-RHEX OPHTHALMIC DIATHERMY SYSTEM (K990064)Ophthalmic Technologies, Inc.1999-04-04
SOF-SUCTION FLUID EVACUATION SYSTEM (K990749)X-Tech Medical, LLC1999-04-02
COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS (K990264)Metro Optics of Austin, Inc.1999-03-31
LPULSA SYL-9000 OPHTHALMIC YAG LASER (K990075)Light-Med(Usa), Inc.1999-03-30
RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T (K983496)Opti-Centre Laboratories1999-03-29
BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER (K983225)Bausch & Lomb, Inc.1999-03-29
DIGISCOPE OPHTHALMIC CAMERA (K990205)Eye Tel Imaging, Inc.1999-03-26
KEELER PULSAIR 3000 NON CONTACT TONOMETER (K990257)Keeler Instruments, Inc.1999-03-25
TETRAFILCON A (K990606)CooperVision, Inc.1999-03-15
ORBSCAN (K984443)Technolas Perfect Vision GmbH1999-03-05
D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (K983797)Dutch Ophthalmic USA, Inc.1999-03-03
ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR (K983160)Hydron , Ltd.1999-02-18
THE FREMSTAD RING (K982599)Ophthalmic Solutions, LLC1999-02-16
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM (K984143)Fibra Sonics, Inc.1999-02-16
IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS (K984523)Igel Vision Care Pte , Ltd.1999-02-16
LOBOB UNIVERSAL CONTACT LENS CLEANER (K990044)Lobob Laboratories, Inc.1999-02-11
RIGID GAS PERMEABLE CONTACT LENS SOLUTION (K983836)Polymer Technology Div. Wilmington Partners, L.P.1999-02-11
PANORAMIC200 OPTHALMOSCOPE (K983999)Optos Plc.1999-02-03
EDI VERIS SYSTEM (K983983)Electro-Diagnostic Imaging, Inc.1999-02-03
BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS (K982947)Ocular Sciences Puerto Rico, Inc.1999-01-29
VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER (K983912)Vistakon, Johnson & Johnson Vision Products, Inc.1999-01-26
FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS (K984273)Ciba Vision Corporation1999-01-25
PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) (K984259)Cl-Tinters1999-01-21
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