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- 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
- 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
- K252682LenSx Laser System (8065000944)2Cleared 510(K)
- K243896LenSx Laser System (8065998162)2Cleared 510(K)
- K223566ELITA™ Femtosecond Laser System, ELITA™ Patient Interface2Cleared 510(K)
- K223838Catalys™ Precision Laser System2Cleared 510(K)
- K220259ALLY Adaptive Cataract Treatment System2Cleared 510(K)
- K220516CATALYS Precision Laser system2Cleared 510(K)
- K213559FEMTO LDV Z8 Femtosecond Surgical Laser2Cleared 510(K)
- K210701CATALYS Precision Laser System2Cleared 510(K)
- K200724VICTUS Femtosecond Laser Platform2Cleared 510(K)
- K200056Catalys Precision Laser System2Cleared 510(K)
- K182795LENSAR Laser System - fs 3D (LLS-fs 3D)2Cleared 510(K)
- K182083Catalys Precision Laser System2Cleared 510(K)
- K181430LENSAR Laser System - fs 3D (LLS-fs 3D)2Cleared 510(K)
- K173660LenSx Laser System2Cleared 510(K)
- K173346LENSAR Laser System - fs 3D (LLS-fs 3D)2Cleared 510(K)
- K171014VICTUS Femtosecond Laser Platform2Cleared 510(K)
- K172002Catalys Precision Laser System2Cleared 510(K)
- K171337LENSAR Laser System – fs 3D (LLS-fs 3D)2Cleared 510(K)
- K170322Catalys Precision Laser System2Cleared 510(K)
- K170576LENSAR Laser System - fs 3D (LLS-fs 3D)2Cleared 510(K)
- K163551LenSx Laser System2Cleared 510(K)
- K161288LenSX Laser System2Cleared 510(K)
- K161455Catalys Precision Laser System2Cleared 510(K)
- K150323FEMTO LDV Z8 Surgical Laser2Cleared 510(K)
- K152453LENSAR Laser System - fs 3D (LLS-fs 3D)2Cleared 510(K)
- K151161VICTUS Femtosecond Laser Platform2Cleared 510(K)
- K143010LENSAR Laser System - fs 3D2Cleared 510(K)
- K141379VICTUS FEMTOSECOND LASER PLATFORM2Cleared 510(K)
- K141476WAVELIGHT FS200 LASER SYSTEM2Cleared 510(K)
- K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEM2Cleared 510(K)
- K140615VICTUS FEMTOSECOND LASER PLATFORM2Cleared 510(K)
- K132534VICTUS FEMTOSECOND LASER PLATFORM2Cleared 510(K)
- K123859TBD2Cleared 510(K)
- K122386VICTUS FEMTOSECOND LASER PLATFORM2Cleared 510(K)
- K123120LENSX LASER SYSTEM2Cleared 510(K)
- K121091CATALYS PRECISION LASER SYSTEM2Cleared 510(K)
- K120426VICTUS LASER PLATFORM2Cleared 510(K)
- K120214TBD2Cleared 510(K)
- K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEM2Cleared 510(K)
- K110427FEMTEC LASER SYSTEM FOR CAPSULOTOMY2Cleared 510(K)
- K112098TBD2Cleared 510(K)
- K102727LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY2Cleared 510(K)
- K101626LENSX LASER SYSTEM2Cleared 510(K)
- K090633LENSAR LASER SYSTEM2Cleared 510(K)
- K094052LENSX 550 LASER SYSTEM. MODEL 5502Cleared 510(K)
- K092647LENSX 550 LASER SYSTEM2Cleared 510(K)
- K082947LENSX 550 LASER SYSTEM2Cleared 510(K)
- 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
FEMTO LDV Z8 Surgical Laser
- Page Type
- Cleared 510(K)
- 510(k) Number
- K150323
- 510(k) Type
- Traditional
- Applicant
- SIE AG,Surgical Instrument Engineering
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/23/2015
- Days to Decision
- 256 days
- Submission Type
- Summary