Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- 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
- 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
- K132042AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND1Cleared 510(K)
- K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM1Cleared 510(K)
- K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS1Cleared 510(K)
- K944700ARCTIC PREMIER SERIES1Cleared 510(K)
- K944857GOGGLE SAFEGUARD1Cleared 510(K)
- K945351SHIELD, EYE, OPHTHALMIC1Cleared 510(K)
- K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)1Cleared 510(K)
- K942407AMCON SLIP IN MYDRIATIC SUNGLASSES1Cleared 510(K)
- K941829SUN FILTERS/SHIELDS1Cleared 510(K)
- K930347SHAIDS PROTECTIVE GLASSES1Cleared 510(K)
- K940275UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELD1Cleared 510(K)
- K940213UNIVERSAL CUSHIONED METAL EYE SHIELD1Cleared 510(K)
- K940095FOX EYE ALUMINUM SHIELD, OPHTHALMIC1Cleared 510(K)
- K930840POST-MYDS(TM)1Cleared 510(K)
- K934085MODIFICATION OF SURGICAL EYESHIELD MASK1Cleared 510(K)
- K931254GOGGLE SAFEGUARD1Cleared 510(K)
- K925564ACTION MEDTEK/DENTEK EYEGLASSES1Cleared 510(K)
- K912576INSTRUMENT WIPE AND CORNEAL SHIELD1Cleared 510(K)
- K913230UNIDIRECTIONAL OCCLUDER1Cleared 510(K)
- K912367EYE BUBBLE1Cleared 510(K)
- K900942OCULAR OCCLUDER1Cleared 510(K)
- K900941OMNIPATCH1Cleared 510(K)
- K896681SOFT CORNEAL LIGHT SHIELD1Cleared 510(K)
- K896171EYE PATCH1Cleared 510(K)
- K896172STRAPPED EYE SHIELD1Cleared 510(K)
- K895364LID LOC1Cleared 510(K)
- K894720UNIVERSAL EYESHIELD1Cleared 510(K)
- K894724SAFE-EDGE EYESHIELD1Cleared 510(K)
- K885163DIOPTICS EYESHIELDS1Cleared 510(K)
- K880489CLEAR EYE GARTER SHIELD1Cleared 510(K)
- K881135COOL EYE(TM) EYE PROTECTOR1Cleared 510(K)
- K880666ULTRAVIOLET LIGHT PROTECTVE EYEWERE1Cleared 510(K)
- K880490BLUE PLASTIC EYE SHIELD1Cleared 510(K)
- K881232SURGIN EYE SHIELD1Cleared 510(K)
- K880675EASY SHIELD ADHESIVE BANDAGE1Cleared 510(K)
- K875302MEDICAL EYE DISPOSABLE SHIELD1Cleared 510(K)
- K875107HEALTH CARE EYE PROTECTION1Cleared 510(K)
- K873662WINK-EASE PERSONAL PROTECTIVE EYEWEAR1Cleared 510(K)
- K872659TAPELESS EYE SHIELD1Cleared 510(K)
- K872000EYE GARD1Cleared 510(K)
- K863474KASEY EYE SHIELD1Cleared 510(K)
- K853035HESSBURG LIGHT GUARD1Cleared 510(K)
- K852404LASERSAFE EYE SHIELDS1Cleared 510(K)
- K844761SCHWARTZ/NORRIS CORNEAL LIGHT SHIELD1Cleared 510(K)
- K843961COLOR OPTIC CORNEAL EYE SHIELD1Cleared 510(K)
- K840834CORNEAL LIGHT SHIELD1Cleared 510(K)
- K840414COLOR OPTIC CORNEAL EYE SHIELD1Cleared 510(K)
- K841599STORZ UNIVERSAL EYE SHIELD1Cleared 510(K)
- K840444NEONATE MASK FOR BABIES1Cleared 510(K)
- K833256CROUCH CORNEAL PROTECTOR1Cleared 510(K)
- K821765PHOTOTHERAPY EYE PROTECTION FOR INFANTS1Cleared 510(K)
- K811577CROUCH CORNEAL PROTECTOR1Cleared 510(K)
- K810098FOX EYE SHIELDS1Cleared 510(K)
- K802786POROPLAST-EYE DRESSING1Cleared 510(K)
- 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
COOL EYE(TM) EYE PROTECTOR
- Page Type
- Cleared 510(K)
- 510(k) Number
- K881135
- 510(k) Type
- Traditional
- Applicant
- COOL EYES, INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/8/1988
- Days to Decision
- 114 days