Anesthesiology
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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
- 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
Blade, Keratome, Reprocessed
- Page Type
- Product Code
- Definition
- Blade for keratome to make flap in cornea for LASIK refractive surgery. Same as previously cleared blade for keratomes, product codes HMY and HNO, except this is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- 510(K)
- Device Classification
- Class 1
- Regulation Number
- 886.4370
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 886.4370 Keratome
§ 886.4370 Keratome.
(a) Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.
(b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]