Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- HLDEngine, Trephine, Accessories, Gas-Powered1Product Code
- HKPInstrument, Vitreous Aspiration And Cutting, Battery-Powered2Product Code
- FCTHeadlight, Fiberoptic Focusing2Product Code
- FSRLight, Headband, Surgical2Product Code
- FTZLocator, Magnetic1Product Code
- HMQMarker, Sclera1Product Code
- HMRMarker, Ocular1Product Code
- HMSDrum, Eye Knife Test1Product Code
- HMXCannula, Ophthalmic1Product Code
- HMYKeratome, Battery-Powered1Product Code
- HMZTrabeculotome1Product Code
- HNASpud, Ophthalmic1Product Code
- HNBSpoon, Ophthalmic1Product Code
- HNCSpecula, Ophthalmic1Product Code
- HNDSpatula, Ophthalmic1Product Code
- HNESnare, Enucleating1Product Code
- HNFScissors, Ophthalmic1Product Code
- HNGRongeur, Lachrymal Sac1Product Code
- HNHRing, Ophthalmic (Flieringa)1Product Code
- HNIRetractor, Ophthalmic1Product Code
- HNJPunch, Corneo-Scleral1Product Code
- HNKProbe, Trabeculotomy1Product Code
- HNLProbe, Lachrymal1Product Code
- HNMNeedle, Ophthalmic Suturing1Product Code
- HNNKnife, Ophthalmic1Product Code
- HNOKeratome, Ac-Powered1Product Code
- K173371VisuMax Femtosecond Laser1Cleared 510(K)
- K172994EPI K Console1Cleared 510(K)
- K072102EPIVISION SL SYSTEM1Cleared 510(K)
- K082043CARRIAZO-PENDULAR MICROKERATOME1Cleared 510(K)
- K062465ZYOPTIX XP EPI SEPARATOR SYSTEM1Cleared 510(K)
- K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM1Cleared 510(K)
- K051486NORWOOD ABBEY CENTURION SES EPIKERATOME1Cleared 510(K)
- K043183EPI-K1Cleared 510(K)
- K043150AMADEUS II EPIKERATOME1Cleared 510(K)
- K042083MODIFICATION TO VISITOME 20-10 MICROKERATOME1Cleared 510(K)
- K042810CENTURION SES EPIKERATOME1Cleared 510(K)
- K041110MB 105 MILLENNIUM BLADES1Cleared 510(K)
- K041206EPITOME SYSTEM1Cleared 510(K)
- K032910CARRIAZO PENDULAR1Cleared 510(K)
- K032836M3 MICROKERATOME1Cleared 510(K)
- K033457M2 COMPATIBLE MICROKERATOME BLADE1Cleared 510(K)
- K033236PRIZM KERATOME BLADE, MODEL MK8512M21Cleared 510(K)
- K040204ZYOPTIX XP MICROKERATOME1Cleared 510(K)
- K033182PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD1Cleared 510(K)
- K033293MED-LOGICS, MODEL ML70901Cleared 510(K)
- K032978MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME1Cleared 510(K)
- K032297DISPOSABLE N-PE MICKROKERATOME BLADES1Cleared 510(K)
- K031735CENTURION SES EPIKERATOME1Cleared 510(K)
- K030401DISPOSABLE M2-PE MICROKERATOME BLADES1Cleared 510(K)
- K030891SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK1Cleared 510(K)
- K020482KERATOME BLADE 200200 & 6006001Cleared 510(K)
- K022982MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB1Cleared 510(K)
- K022716MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB1Cleared 510(K)
- K022205DISPOSABLE N-PE MICROKERATOME BLADES1Cleared 510(K)
- K021640HANSATOME EXCELLUS MICROKERATOME1Cleared 510(K)
- K020079BLADEWORKS MICROKERATOME BLADE, MODEL 70611Cleared 510(K)
- K014000VISTITOME 20-10 MICROKERATOME1Cleared 510(K)
- K020122MB 102 MILLENNIUM BLADES1Cleared 510(K)
- K011833MB 103 MILLENNIUM BLADES1Cleared 510(K)
- K013337PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI1Cleared 510(K)
- K011195PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB1Cleared 510(K)
- K010872ML BLADE, MODEL ML70301Cleared 510(K)
- K010260HANSATOME MICROKERATOME1Cleared 510(K)
- K003820DISPOSABLE CB-PE MICROKERATOME BLADES1Cleared 510(K)
- K002515MEDLOGICS ML 4000, MODEL 40001Cleared 510(K)
- K003143MILLENNIUM BLADES, MODEL MB1011Cleared 510(K)
- K002849PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES1Cleared 510(K)
- K001464DISPOSABLE H-PE MICROKERATOME BLADES1Cleared 510(K)
- K001176DISPOSABLE MICROKERATOME BLADES-PE1Cleared 510(K)
- K001806REFRACTIVE SURGERY BLADES1Cleared 510(K)
- K001144ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS1Cleared 510(K)
- K993225BLADEWORKS MICROKERATOME BLADE1Cleared 510(K)
- K993122MSP M/K BLADE1Cleared 510(K)
- K994015ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK85081Cleared 510(K)
- K993190ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)1Cleared 510(K)
- K990227ULTRASHAPER KERATOME1Cleared 510(K)
- K992978RICROKERATOME BLADE1Cleared 510(K)
- K990900MICROKERATOME, MODEL MK-20001Cleared 510(K)
- K984540KERAVISION VACUUM RING SYSTEM1Cleared 510(K)
- K981554MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)1Cleared 510(K)
- K980675SUMMIT KRUMEICH-BARRAQUER MICROKERATOME1Cleared 510(K)
- K983317BARRON MICROKERATOME SYSTEM, MODEL B20001Cleared 510(K)
- K981742ONE UP DISPOSABLE KERATOME HEAD1Cleared 510(K)
- K981155FLAPMAKER DISPOSABLE MICROKERATOME1Cleared 510(K)
- K981071ML MICROKERATOME1Cleared 510(K)
- K980985SCMD-10001Cleared 510(K)
- K980508KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 4004001Cleared 510(K)
- K980510KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)1Cleared 510(K)
- K974598MICROKERATOME OR THE MATE1Cleared 510(K)
- K980924PLANCON MICROLAMELLAR KERATOME EVOLUTION1Cleared 510(K)
- K974004AUTOMATED DISPOSABLE KERATOME (ADK)1Cleared 510(K)
- K972808HANSATOME MICROKERATOME1Cleared 510(K)
- K972727CBALK-1000 BLADE1Cleared 510(K)
- K973294INNOVATOME MICROKERATOME1Cleared 510(K)
- K970377PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)1Cleared 510(K)
- K962661ML MICROKERATOME BLADE1Cleared 510(K)
- K960395PLANCON MIRCOLAMELLAR KERATOME1Cleared 510(K)
- K954058BARRAQUER-KRUMEICH REFRACTIVE SET1Cleared 510(K)
- K941550AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT1Cleared 510(K)
- K935342SCMD KERATOME1Cleared 510(K)
- K913697AUTOMATIC CORNEAL SHAPER1Cleared 510(K)
- K911062QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY1Cleared 510(K)
- K904845STORZ DRAEGER ROTOR KERATOME1Cleared 510(K)
- K903912KERATOME1Cleared 510(K)
- K870807BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE1Cleared 510(K)
- K864065BKS-42 DISPOSABLE VACUUM TUBING PACK1Cleared 510(K)
- K860001BARRAQUER-KRUMEICH REFRACTIVE SET1Cleared 510(K)
- K760726ELECTRO-KERATOTOME, LINE-OPERATED1Cleared 510(K)
- HNPIntroducer, Sphere1Product Code
- HNQHook, Ophthalmic1Product Code
- HNRForceps, Ophthalmic1Product Code
- HNSExpressor1Product Code
- HNTErisophake1Product Code
- HNWDilator, Lachrymal1Product Code
- HNXDepressor, Orbital1Product Code
- HNYCystotome1Product Code
- HNZCurette, Ophthalmic1Product Code
- HOACompressor, Orbital1Product Code
- HOBClamp, Muscle, Ophthalmic1Product Code
- HOCClip, Iris Retractor1Product Code
- HODClamp, Eyelid, Ophthalmic1Product Code
- HOECaliper, Ophthalmic1Product Code
- HOFBurr, Corneal, Manual1Product Code
- HOGBurr, Corneal, Battery-Powered1Product Code
- HOHSpectacle, Operating (Loupe), Ophthalmic1Product Code
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)1Product Code
- HOZSponge, Ophthalmic2Product Code
- HPMLocator, Metal, Electronic2Product Code
- HPNMagnet, Permanent1Product Code
- HPOMagnet, Ac-Powered2Product Code
- HPPHeadlamp, Operating, Battery-Operated1Product Code
- HPQHeadlamp, Operating, Ac-Powered2Product Code
- HPSUnit, Cryophthalmic2Product Code
- HPYUnit, Electrolysis, Battery-Powered, Ophthalmic1Product Code
- HQAUnit, Cryotherapy, Ophthalmic2Product Code
- HQBPhotocoagulator And Accessories2Product Code
- HQCUnit, Phacofragmentation2Product Code
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2Product Code
- HQFLaser, Ophthalmic2Product Code
- HQOUnit, Cautery, Thermal, Ac-Powered2Product Code
- HQPUnit, Cautery, Thermal, Battery-Powered2Product Code
- HQQApparatus, Cautery, Radiofrequency, Battery-Powered2Product Code
- HQRApparatus, Cautery, Radiofrequency, Ac-Powered2Product Code
- HQSBurr, Corneal, Ac-Powered1Product Code
- HRFEngine, Trephine, Accessories, Battery-Powered1Product Code
- HRGEngine, Trephine, Accessories, Ac-Powered1Product Code
- HRHTrephine, Manual, Ophthalmic1Product Code
- HRJTable, Instrument, Powered, Ophthalmic1Product Code
- HRKTable, Instrument, Manual, Ophthalmic1Product Code
- HRNUnit, Cryophthalmic, Ac-Powered2Product Code
- HROUnit, Electrolysis, Ac-Powered, Ophthalmic2Product Code
- HRPPen, Marking, Surgical1Product Code
- KYBLens, Guide, Intraocular1Product Code
- KYGDevice, Irrigation, Ocular Surgery1Product Code
- LCCApplicator, Ocular Pressure2Product Code
- LPOGases Used Within Eye To Place Pressure On Detached Retina3Product Code
- LQJLens, Surgical, Laser, Accesssory, Ophthalmic Laser2Product Code
- LWLFluid, Intraocular3Product Code
- LXPPlug, Scleral2Product Code
- LXSLaser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla2Product Code
- LZPAid, Surgical, Viscoelastic3Product Code
- MLZVitrectomy, Instrument Cutter2Product Code
- MMCDilator, Expansive Iris (Accessory)2Product Code
- MOECollagen Corneal Shield1Product Code
- MSRTubing, Replacement, Phacofragmentation Unit2Product Code
- MSSFolders And Injectors, Intraocular Lens (Iol)1Product Code
- MUSFluidic, Phacoemulsification/Phacofragmentation2Product Code
- MXOLaser, System, Phacolysis2Product Code
- MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal1Product Code
- MYDKeratome, Water Jet1Product Code
- NCEInjector, Capsular Tension Ring1Product Code
- NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered2Product Code
- NGYCannula, Trocar, Ophthalmic1Product Code
- NKXNeedle, Phacoemulsification, Reprocessed2Product Code
- NKYBlade, Keratome, Reprocessed1Product Code
- NLAKnife, Ophthalmic, Reprocessed1Product Code
- NVBIntraocular, Pressure Measuring Device3Product Code
- OHWBurr, Corneal, Battery Powered, Rust Ring Removal1Product Code
- OHXBurr, Corneal, Ac-Powered, Rust Ring Removal1Product Code
- OJKEye Tray2Product Code
- OOEOphthalmic Femtosecond Laser2Product Code
- OTZGraft Insertion Instrument For Endothelial Keratoplasty1Product Code
- PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered2Product Code
- PZGSurgical Eye Tray1Product Code
- QDVIol Tray1Product Code
- QDWPhaco Kit2Product Code
- QDYVitrectomy Kit2Product Code
- QGJCorneal Inlay Inserter Handle1Product Code
- QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Product Code
- PYUSponge, Eyelid Cleaning, Powered1Product Code
- QUQKnife, Intraocular Pressure Lowering2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K013337
- 510(k) Type
- Traditional
- Applicant
- SURGIN INC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/13/2001
- Days to Decision
- 65 days
- Submission Type
- Statement