Review Panel
Ophthalmic FDA 510(k) Clearances & Devices
- Cleared Devices
- 4,756
- Product Codes (page)
- 31
- Latest Decision
- 1999-02-03
Clearances · page 18 of 48
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K983999 | PANORAMIC200 OPTHALMOSCOPE | Optos Plc. | HLI | Class II | 1999-02-03 |
| K983983 | EDI VERIS SYSTEM | Electro-Diagnostic Imaging, Inc. | HLX | Class II | 1999-02-03 |
| K982947 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTACT LENS | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | 1999-01-29 |
| K983912 | VISTAKON (LENEFILCON A)CONTACT LENS CLEAR AND VISIBILITY TINT WITH UV BLOCKER | Vistakon, Johnson & Johnson Vision Products, Inc. | LPL | Class II | 1999-01-26 |
| K984273 | FOCUS DAILIES VISITINT (NELFILCON A) ONE-DAY CONTACT LENS | Ciba Vision Corporation | MVN | Class II | 1999-01-25 |
| K984259 | PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Cl-Tinters | LPL | Class II | 1999-01-21 |
| K984046 | BIOMEDICS 55 (OCUFILCON D) UV BLOCKING SOFT (HYDROPHILIC) CONTAC LENS | Ocular Sciences Puerto Rico, Inc. | LPL | Class II | 1999-01-21 |
| K982997 | FREQUENCY 55 UV (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED WITH UV BLOCKER) | Aspect Vision Care, Ltd. | LPL | Class II | 1999-01-20 |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | LPN | Class II | 1999-01-14 |
| K982115 | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY | Rim-Wide Companies, Inc. | LYL | Class II | 1999-01-13 |
| K981432 | GOLDMAN MANUAL TONOMETER | Golden Vision, Inc. | HKY | Class II | 1999-01-12 |
| K983607 | LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS | Labtician Ophthalmics, Inc. | MML | Class II | 1999-01-08 |
| K982988 | PRECISION UV (VASURFILCON A) | Wesley Jessen Corp. | LPL | Class II | 1999-01-06 |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | HPZ | Class II | 1998-12-28 |
| K980675 | SUMMIT KRUMEICH-BARRAQUER MICROKERATOME | Summit Technology, Inc. | HNO | Class I | 1998-12-22 |
| K982344 | DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS | Wesley Jessen Corp. | LPL | Class II | 1998-12-22 |
| K983773 | BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS | Benz Research and Development Corp. | LPL | Class II | 1998-12-22 |
| K981554 | MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) | Micra Instruments , Ltd. | HNO | Class I | 1998-12-22 |
| K983448 | ML UNIVERSAL TUBING | Med-Logics, Inc. | MSR | Class II | 1998-12-18 |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Alcon Laboratories | LPN | Class II | 1998-12-18 |
| K984383 | ULTRACARE NEUTRALIZING TABLETS | Allergan, Inc. | LPN | Class II | 1998-12-18 |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | LPN | Class II | 1998-12-18 |
| K981665 | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE | Bio-Medical Sciences, Inc. | MMQ | Class I | 1998-12-07 |
| K983129 | DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1) | Staar Surgical Co. | KYB | Class I | 1998-12-04 |
| K983317 | BARRON MICROKERATOME SYSTEM, MODEL B2000 | Barron Precision Instruments, LLC | HNO | Class I | 1998-12-02 |
| K983291 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | MRC | Class II | 1998-11-25 |
| K983150 | COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | LPN | Class II | 1998-11-25 |
| K983278 | OXYLENS TINTED, PROSTHETIC (HIOXIFILCON B) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AN NON-SIGHTED EYES) | Alden Optical Labs., Inc. | LPL | Class II | 1998-11-25 |
| K983894 | BAUSCH & LOMB PHOENIX (HILAFILCON A) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | LPL | Class II | 1998-11-18 |
| K982168 | SOLO-CARE BRAND MULTI-PURPOSE SOLUTION | Ciba Vision Corporation | LPN | Class II | 1998-11-17 |
| K983021 | METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC | Metrosoft, Inc. | LPL | Class II | 1998-11-13 |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | HQX | Class II | 1998-11-06 |
| K982110 | POLYVUE 43 (OCUFILCON A) SPHERICAL, TORIC AND ASPHERICAL MULTIFOCAL HYDROPHILIC CONTACT LENSES FOR DAILY WEAR | Optech, Inc. | LPL | Class II | 1998-11-06 |
| K982775 | BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | LPN | Class II | 1998-11-03 |
| K982689 | WINSTATION RETINAL IMAGER | Ophthalmic Imaging Systems | HKI | Class II | 1998-10-23 |
| K983053 | ALDEN CLASSIC PROSTHETIC (POLYMACON) TINTED, SOFT DAILY WEAR CONTACT LENS (SIGHTED AND NON-SIGHTED EYES) | Alden Optical Labs., Inc. | LPL | Class II | 1998-10-21 |
| K980816 | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | HQX | Class II | 1998-09-18 |
| K980696 | FOAM TIP INJECTOR | Staar Surgical Co. | MSS | Class I | 1998-09-11 |
| K982774 | SOFT (HYDROPHILIC) CONTACT LENSES | Cl-Tinters | LPL | Class II | 1998-09-02 |
| K982904 | ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS | Les Laboratoires Blanchard | LPL | Class II | 1998-09-01 |
| K981168 | COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS | Allergan, Inc. | LPN | Class II | 1998-09-01 |
| K981742 | ONE UP DISPOSABLE KERATOME HEAD | Moria, Inc. | HNO | Class I | 1998-08-25 |
| K981989 | THE WAVE DIGITAL PHACO SYSTEM | Circuit Tree | HQC | Class II | 1998-08-25 |
| K982057 | BC 900 SLIT LAMP | Haag-Streit AG | HJO | Class II | 1998-08-14 |
| K974535 | DISCAM DIGITAL IMAGING SYSTEM | Marcher Enterprises, Ltd. | HKI | Class II | 1998-08-14 |
| K981155 | FLAPMAKER DISPOSABLE MICROKERATOME | Hawken Industries | HNO | Class I | 1998-08-14 |
| K981640 | S2LO | Odyssey Optical Systems, LLC | HLI | Class II | 1998-08-05 |
| K980197 | ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR | Specialty Ultravision, Inc. | HQD | Class II | 1998-08-04 |
| K981561 | LIQUID ENZYME ID 90133 | Alcon Laboratories | LPN | Class II | 1998-07-24 |
| K981741 | CARRIAZO BARRAQUER MICROKERATOME | Moria, Inc. | HMY | Class I | 1998-07-24 |
| K981071 | ML MICROKERATOME | Med-Logics, Inc. | HNO | Class I | 1998-07-23 |
| K980522 | REFRACTEC MCS-100 | Refractec, Inc. | HQR | Class II | 1998-07-22 |
| K981235 | OCULOSTAT | Laser Center Dev. Corp. | HNC | Class I | 1998-07-15 |
| K980822 | TITANIUM PEG SYSTEM | Fci Ophthalmics, Inc. | MQU | Class II | 1998-07-09 |
| K981571 | MONARCH IOL DELIVERY SYSTEM | Alcon Laboratories | KYB | Class I | 1998-07-09 |
| K980849 | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | MSR | Class II | 1998-07-09 |
| K980775 | COMPLETE BRAND MULTI-PURPOSE SOLUTION | Allergan, Inc. | LPN | Class II | 1998-07-06 |
| K981574 | OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION | Alcon | LPN | Class II | 1998-07-06 |
| K974837 | IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS | Igel Vision Care Pte , Ltd. | LPL | Class II | 1998-07-06 |
| K981779 | CANTOR & SILVER 5X (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINTED, LAT | Cantor & Silver , Ltd. | LPL | Class II | 1998-06-24 |
| K980591 | RENU MULTIPLUS LUBRICATING & REWETTING DROPS | Bausch & Lomb, Inc. | LPN | Class II | 1998-06-24 |
| K981063 | AUTOMATED CORNEAL TREPHINE | Laser Center Dev. Corp. | HRG | Class I | 1998-06-23 |
| K981252 | OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR) | Alden Optical Labs., Inc. | LPL | Class II | 1998-06-23 |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Alcon Laboratories | HQC | Class II | 1998-06-23 |
| K981151 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONING AND DISINFECTING SOLUTION ID 84392 | Alcon Laboratories | LPN | Class II | 1998-06-22 |
| K981196 | MEDITEC LINK | Aesculap-Meditec North America | HQF | Class II | 1998-06-17 |
| K981109 | QUITETIP | Paradigm Medical Industries, Inc. | HQC | Class II | 1998-06-09 |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Storz Instrument Co. | MSR | Class II | 1998-06-01 |
| K980292 | CATARACT LIQUEFRACTURE DEVICE | Alcon Laboratories | MUS | Class II | 1998-05-19 |
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | KYG | Class I | 1998-05-19 |
| K980295 | OPHTHAVISION IMAGING SYSTEM | Mrp Group, Inc. | HKI | Class II | 1998-05-19 |
| K980647 | EYE IRRIGATOR MODEL #2020 | Eye-Deal Ocular Safety Products, Inc. | KYG | Class I | 1998-05-15 |
| K980649 | PREFERENCE STANDARD, PREFERENCE TORIC, COOPER TORIC, COOPERCLEAR, COOPERHT, CB 43, VANTAGE, VANTAGE ACCENTS | CooperVision, Inc. | LPL | Class II | 1998-05-13 |
| K980741 | BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B) | Polymer Technology Div. Wilmington Partners, L.P. | HQD | Class II | 1998-05-11 |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | Canon USA, Inc. | HKI | Class II | 1998-05-06 |
| K980480 | SYNTEC VITMAN | Syntec, Inc. | HQC | Class II | 1998-05-04 |
| K980510 | KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020) | Micro Specialties, Inc. | HNO | Class I | 1998-05-01 |
| K980508 | KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400 | Micro Specialties, Inc. | HNO | Class I | 1998-05-01 |
| K980985 | SCMD-1000 | Howard Instruments, Inc. | HNO | Class I | 1998-05-01 |
| K980399 | PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20 | Peregrine Surgical , Ltd. | HQE | Class II | 1998-04-30 |
| K980400 | PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 | Peregrine Surgical , Ltd. | HQE | Class II | 1998-04-30 |
| K980357 | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER | Konan, Inc. | HKI | Class II | 1998-04-24 |
| K980634 | FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) | Aspect Vision Care, Ltd. | LPL | Class II | 1998-04-22 |
| K974598 | MICROKERATOME OR THE MATE | Howard Instruments, Inc. | HNO | Class I | 1998-04-22 |
| K980657 | AHMED GLAUCOMA VALVE, MODEL S3 | New World Medical, Inc. | KYF | Class II | 1998-04-20 |
| K974408 | PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS | Biocompatibles Eyewear, Inc. | LPL | Class II | 1998-04-16 |
| K980924 | PLANCON MICROLAMELLAR KERATOME EVOLUTION | Plancon Instruments | HNO | Class I | 1998-04-15 |
| K980147 | YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION | Automatic Liquid Packaging, Inc. | LPN | Class II | 1998-04-13 |
| K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY | Airperm, Inc. | MUW | Class II | 1998-04-08 |
| K980554 | ALDEN CLASSIC TINTED (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS, TINTED (TRANSPARENT/ENHANCING) | Alden Optical Labs., Inc. | LPL | Class II | 1998-04-07 |
| K973064 | KEELER TEARSCOPE-PLUS | Keeler Instruments, Inc. | HJO | Class II | 1998-04-07 |
| K980818 | POLYVUE, SILVER CHORD AND UNISOFT (METHAFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL HYDROPHILIC CONTACT LENSE) | Stephen A. Dunn, Inc. | LPL | Class II | 1998-03-30 |
| K974636 | FLOSI RIGID GAS PERMEABLE CONTACT LENS | Futuristic Design Assoc. | HQD | Class II | 1998-03-30 |
| K980488 | STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM | Storz Instrument Co. | HQE | Class II | 1998-03-23 |
| K980218 | METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR | Biocompatibles Eyewear, Inc. | LPL | Class II | 1998-03-23 |
| K972749 | PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S) | C.M. Chance , Ltd. | HQR | Class II | 1998-03-13 |
| K974780 | SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS | Bausch & Lomb, Inc. | LPL | Class II | 1998-03-11 |
| K980133 | BAUSCH & LOMB WETTING AND SOAKING SOLUTION | Polymer Technology Corp. | LPN | Class II | 1998-03-11 |
| K974723 | RENU MULTIPLUS MULTI-PURPOSE SOLUTION | Bausch & Lomb, Inc. | LPN | Class II | 1998-03-10 |
| K974624 | ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Alcon Laboratories | LPN | Class II | 1998-03-04 |
4,756 clearances in the Ophthalmic panel. Data: openFDA.