meddevicedb.com FDA Device Reference

Review Panel

Ophthalmic FDA 510(k) Clearances & Devices

Cleared Devices
4,756
Product Codes (page)
30
Latest Decision
2000-03-20

Clearances · page 17 of 48

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K993357 IOLMASTER Carl Zeiss, Inc. HJO Class II 2000-03-20
K000439 DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C Wesley Jessen Corp. LPL Class II 2000-03-20
K993225 BLADEWORKS MICROKERATOME BLADE Blade Works, Inc. HNO Class I 2000-03-20
K991840 FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER Bernard B. Fresco HKY Class II 2000-03-20
K994335 PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS Wesley Jessen Corp. LPL Class II 2000-03-20
K993122 MSP M/K BLADE Medical Sterile Products, Inc. HNO Class I 2000-03-16
K994015 ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 Surgin Surgical Instrumentation, Inc. HNO Class I 2000-03-15
K000544 BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 Labtician Ophthalmics, Inc. HJX Class I 2000-03-09
K000384 FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX CooperVision, Inc. LPL Class II 2000-03-06
K994125 BAUSCH & LOMB 2-WEEK (HILAFILCON B) VISIBILITY TINTED CONTACT LENSES Bausch & Lomb, Inc. LPL Class II 2000-03-03
K994170 HYLASHIELD CL Biomatrix, Inc. MRC Class II 2000-03-02
K994318 VISTAKON (LENEFILCON A)SOFT(HYDROPHILIC)CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER Vistakon, Johnson & Johnson Vision Products, Inc. LPL Class II 2000-02-23
K994324 ACUVUE (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS CLEAR AND VISIBILITY TINTED WITH UV BLOCKER Vistakon, Johnson & Johnson Vision Products, Inc. LPL Class II 2000-02-23
K994021 CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION Strieter Clinical Research Laboratories, Inc. LYL Class II 2000-02-22
K993190 ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS) Surgical Instrument Systems (Sis), Ltd. HNO Class I 2000-02-10
K992787 EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR Specialty Ultravision, Inc. HQD Class II 2000-02-02
K993580 SPECIALTY 55 (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR Specialty Ultravision, Inc. LPL Class II 2000-02-02
K990227 ULTRASHAPER KERATOME Lasersight Technologies, Inc. HNO Class I 2000-01-31
K994019 CAUTERY GRASPER/DISSECTOR Starion Instruments HQP Class II 2000-01-20
K992998 AUTOMATED OPHTHALMICS SOFTIPS Automated Ophthalmics, Inc. HKY Class II 2000-01-10
K993949 SOLO-CARE BRAND HARD SOLUTION Ciba Vision Corporation MRC Class II 2000-01-05
K993361 TUBING EXTENSION SET Hurricane Medical MSR Class II 2000-01-04
K993591 BLADEWORKS DISPOSABLE ALK TUBING Blade Works, Inc. KYG Class I 1999-12-28
K993486 PARAGON LENS CARRIER Paragon Vision Sciences LRX Class II 1999-12-22
K993487 PARAGON LENS VIAL Paragon Vision Sciences LRX Class II 1999-12-22
K992954 KEELER CRYO MASTER & PROBES Keeler Instruments, Inc. HRN Class II 1999-12-21
K993883 M-PACT CORNEAL LIGHT SHIELD M-Pact Corp. HOZ Class II 1999-12-21
K993935 DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI Wesley Jessen Corp. LPL Class II 1999-12-21
K992943 VIT ENHANCER Medical Instrument Development Laboratories, Inc. HQE Class II 1999-12-10
K983637 ACTIFRESH 400 LENS Hydron , Ltd. LPL Class II 1999-12-10
K993252 METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP CooperVision, Inc. MVN Class II 1999-11-24
K992264 OCULAR SCIENCES, INC., BIOMEDICS 60 (OCUFILCON F) UV BLOCKING DAILY WEAR SOFT CONTACT LENS Ocular Sciences Puerto Rico, Inc. LPL Class II 1999-11-24
K990292 I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN Ophthalmic Consultants, Inc. HQE Class II 1999-11-19
K984219 COLORMAX COLOR VISION ENHANCEMENT LENSES Color Vision Technologies, Inc. NAI Class I 1999-11-18
K992950 CUSTOM PROSTHETIC (HEFILCON A) SOFT LENS Prosthetic Soft Lens Corp. LPL Class II 1999-11-18
K992978 RICROKERATOME BLADE Surgistar, Inc. HNO Class I 1999-11-16
K992836 SL990, SL980, SL950 Cso HJO Class II 1999-11-09
K991592 KSEA DE LA PLAZA BLEPHAROPLASTY SET KARL STORZ Endoscopy-America, Inc. HNI Class I 1999-11-02
K991015 LM-70 (LIDOFILCON A) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, LATHE-CUT) Lamda Polytech , Ltd. LPL Class II 1999-11-02
K992692 EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS Benz Research and Development Corp. LPL Class II 1999-10-18
K992028 REFRESH CONTACTS LUBRICATING AND REWETTING DROPS Allergan, Inc. LPN Class II 1999-10-07
K992466 OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR Ocu-Ease Optical Products, Inc. LPL Class II 1999-10-04
K991965 PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES Purilens, Inc. LYL Class II 1999-10-01
K992687 MILLENIUM MICROKERATOME, MODEL IMD-001 Industrial & Medical Design, Inc. HMY Class I 1999-09-24
K990900 MICROKERATOME, MODEL MK-2000 Nidek, Inc. HNO Class I 1999-09-24
K991620 VISINE FOR CONTACTS Pfizer, Inc. LPN Class II 1999-09-24
K984573 OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP Alcon Laboratories LPN Class II 1999-09-16
K991125 SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES Sauflon Pharmaceuticals, Ltd. LPN Class II 1999-09-14
K991995 SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS Softchrome, Inc. MZD Class II 1999-08-27
K992589 RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY Opti-Centre Laboratories LPL Class II 1999-08-26
K992500 CANTOR & SILVER 5X PROSTHETIC TINTED (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS Cantor & Silver , Ltd. LPL Class II 1999-08-18
K992446 DAILIES (NELFILCON A) ONE-DAY Ciba Vision Johns Creek Mfg. MVN Class II 1999-08-18
K992339 COLORSOFT PROSTHETIC TINTED SOFT CONTACT LENS Colorsoft Laboratories Corp. LPL Class II 1999-08-16
K991284 ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM Nidek, Inc. MXK Class II 1999-08-06
K991403 SOLO-CARE BRAND MULTI-PURPOSE SOLUTION Ciba Vision Corporation LPN Class II 1999-07-16
K990872 SCLERAL PLUGS, 19 AND 20 GAUGE Ophthalmic Consultants, Inc. LXP Class II 1999-07-13
K991072 AHMED GLAUCOMA VALVE IMPLANT New World Medical, Inc. KYF Class II 1999-07-13
K992054 ADVENTURE TINTS PROSTHETIC TINTED SOFT CONTACT LENS Adventures IN Color Technology, Ltd. LPL Class II 1999-07-07
K991852 OCUSYSTEM ART ADVANTAGE, MODEL 995 Surgical Design Corp. HQC Class II 1999-07-07
K984090 SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR, SPECIALITY 55 (METHAFILCON A) Specialty Ultravision, Inc. LPL Class II 1999-07-07
K991781 FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS G.T. Laboratories, Inc. HQD Class II 1999-06-29
K992010 W-55 (METHAFILCON A) CLEAR AND VISIBILITY TINTED LENS BLANK AND HORIZON 55 SOFT (CLEAR) AND HORIZON 55 WESTINT (TINTED) Westcon Contact Lens Co., Inc. LPL Class II 1999-06-29
K991780 FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C G.T. Laboratories, Inc. HQD Class II 1999-06-29
K991000 GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES Wesley Jessen Corp. LPL Class II 1999-06-28
K991163 VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR Vistakon, Johnson & Johnson Vision Products, Inc. LPL Class II 1999-06-08
K990869 LEICA AT550 Leica Microsystems, Inc. HKX Class II 1999-06-07
K990728 THERMAL CAUTERY DEVICE, FORCEPS Starion Instruments HQP Class II 1999-06-03
K990815 COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS Colorsoft Laboratories Corp. LPL Class II 1999-06-03
K990665 BQ/BM INTEGRATED LASER DELIVERY SYSTEM American Laser Corp. HQF Class II 1999-05-17
K984537 KERATOME SYSTEM, MODEL K3000 Insight Technologies Instruments, LLC HMY Class I 1999-05-14
K991550 FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS Wesley Jessen Corp. LPL Class II 1999-05-14
K990011 CONTINENTAL 45 TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WEAR Continental Soft Lens, Inc. LPL Class II 1999-05-11
K990671 DRAINAGE WICK; SURGICAL SPEARS AND SPONGES, CORNEAL LIGHT SHIELD, INSTRUMENT WIPE Hurricane Medical HOZ Class II 1999-05-10
K984098 ADVENTURE TINTS, COLOR ENHANCED TINTED SOFT CONTACT LENS Adventures IN Color Technology, Ltd. LPL Class II 1999-05-10
K990480 OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER Alcon Laboratories LPN Class II 1999-05-10
K991134 ACUVUE (ETAFILCON A)SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND VISIBILITY TINT, WITH UV BLOCKER, FOR DAILY WEAR Vistakon, Johnson & Johnson Vision Products, Inc. LPL Class II 1999-05-06
K984540 KERAVISION VACUUM RING SYSTEM Keravision, Inc. HNO Class I 1999-04-28
K990422 RENU MULTIPLUS MULTI-PURPOSE SOLUTION Bausch & Lomb, Inc. LPN Class II 1999-04-27
K990757 CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT WEAR CONTACT LENS, TINTED (TRANSPA Cantor & Silver , Ltd. LPL Class II 1999-04-21
K984436 PVS BASICS Paragon Vision Sciences HQD Class II 1999-04-21
K990281 S-38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS, THE ESSTECH PS & SV (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS Nissel , Ltd. LPL Class II 1999-04-16
K990895 OXYCON LENS Concise Contact Lens Co. HQD Class II 1999-04-14
K990224 LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET Labtician Ophthalmics, Inc. MML Class II 1999-04-12
K990064 DI-RHEX OPHTHALMIC DIATHERMY SYSTEM Ophthalmic Technologies, Inc. HQR Class II 1999-04-04
K990749 SOF-SUCTION FLUID EVACUATION SYSTEM X-Tech Medical, LLC HOZ Class II 1999-04-02
K990264 COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS Metro Optics of Austin, Inc. HQD Class II 1999-03-31
K990075 LPULSA SYL-9000 OPHTHALMIC YAG LASER Light-Med(Usa), Inc. HQF Class II 1999-03-30
K983225 BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER Bausch & Lomb, Inc. LPN Class II 1999-03-29
K983496 RESOLUTION 45 (SPHERICAL) AND ULTRA GEL (TORIC) (HIOXIFILCON B) SOFT DAILY WEAR CONTACT LENS, )CLEAR & BLUE VISIBILITY T Opti-Centre Laboratories LPL Class II 1999-03-29
K990205 DIGISCOPE OPHTHALMIC CAMERA Eye Tel Imaging, Inc. HKI Class II 1999-03-26
K990257 KEELER PULSAIR 3000 NON CONTACT TONOMETER Keeler Instruments, Inc. HKX Class II 1999-03-25
K990606 TETRAFILCON A CooperVision, Inc. LPL Class II 1999-03-15
K984443 ORBSCAN Technolas Perfect Vision GmbH MXK Class II 1999-03-05
K983797 D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM Dutch Ophthalmic USA, Inc. HQE Class II 1999-03-03
K983160 ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR Hydron , Ltd. LPL Class II 1999-02-18
K984523 IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS Igel Vision Care Pte , Ltd. LPL Class II 1999-02-16
K984143 FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM Fibra Sonics, Inc. HQC Class II 1999-02-16
K982599 THE FREMSTAD RING Ophthalmic Solutions, LLC HOZ Class II 1999-02-16
K990044 LOBOB UNIVERSAL CONTACT LENS CLEANER Lobob Laboratories, Inc. LPN Class II 1999-02-11
K983836 RIGID GAS PERMEABLE CONTACT LENS SOLUTION Polymer Technology Div. Wilmington Partners, L.P. MRC Class II 1999-02-11

4,756 clearances in the Ophthalmic panel. Data: openFDA.