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
- HKXTonometer, Ac-Powered2Product Code
- HKYTonometer, Manual2Product Code
- K241447iCare ST500 (TA04)2Cleared 510(K)
- K233516Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)2Cleared 510(K)
- K234037CATS-L Tonometer™ Prism2Cleared 510(K)
- K232143Applanation Tonometer HT-50002Cleared 510(K)
- K220852iCare IC2002Cleared 510(K)
- K211355iCare HOME22Cleared 510(K)
- K203850CATS®-D Tonometer Prism2Cleared 510(K)
- K200966Icare HOME Tonometer2Cleared 510(K)
- K190316Icare ic2002Cleared 510(K)
- K191314Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q2Cleared 510(K)
- K182491Applanation tonometer AT-22Cleared 510(K)
- K180839AT 0302Cleared 510(K)
- K173904CATS Tonometer Prism2Cleared 510(K)
- K172728Applanation tonometer AT-12Cleared 510(K)
- K163343Icare HOME tonometer2Cleared 510(K)
- K153694Icare ic1002Cleared 510(K)
- K142263Applanation Tonometer2Cleared 510(K)
- K151491Falck Medical Multifunction Tonometer, FAT12Cleared 510(K)
- K152644KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 1002Cleared 510(K)
- K152308Sensor Medical Single Use Tonometer Prism2Cleared 510(K)
- K142179D-KAT Z-YPE2Cleared 510(K)
- K132549ACCUTIP COVER2Cleared 510(K)
- K133234T-TYPE D-KAT, R-TYPE D-KAT2Cleared 510(K)
- K132917OCULAR FORCE GAUGE2Cleared 510(K)
- K093445KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)2Cleared 510(K)
- K071755FALCK APPLANATION TONOMETER (FAT2)2Cleared 510(K)
- K063873ICARE TONOMETER TA01I2Cleared 510(K)
- K070534MODIFICATION TO: OCU-FILM TIP COVER2Cleared 510(K)
- K053430TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER2Cleared 510(K)
- K033146TONO-PEN TONOMETER TIP COVER2Cleared 510(K)
- K032967PASCAL DYNAMIC CONTOUR TONOMETER2Cleared 510(K)
- K032769EYESOPEN TONOMETER2Cleared 510(K)
- K023838LUNEAU STERILE TONOMETER SEPARATION PRISMS2Cleared 510(K)
- K022054F 9002Cleared 510(K)
- K011199PROVIEW EYE PRESSURE MONITOR2Cleared 510(K)
- K992835C.S.O. TONOMETER2Cleared 510(K)
- K000288REICHERT CT200 CONTACT TONOMETER2Cleared 510(K)
- K991840FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER2Cleared 510(K)
- K992998AUTOMATED OPHTHALMICS SOFTIPS2Cleared 510(K)
- K981432GOLDMAN MANUAL TONOMETER2Cleared 510(K)
- K970887BLOOD FLOW ANALYZER2Cleared 510(K)
- K964312MENTOR TONO-PEN 32Cleared 510(K)
- K961512PERKINS HAND-HELD APPLANATION TONOMETER2Cleared 510(K)
- K960924KOWA HAND-HELD APPLANATION TONOMETER HA-12Cleared 510(K)
- K945446BOBES TONOMETER2Cleared 510(K)
- K945541SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE2Cleared 510(K)
- K924760TOMEY PROTON TONOMETER2Cleared 510(K)
- K923877TONOSHIELD TONOMETER SHIELD2Cleared 510(K)
- K882750OCU-FILM TIP COVER2Cleared 510(K)
- K860330MAKLAKOV STYLE TONOMETER2Cleared 510(K)
- K852774OCULAB TONOPEN2Cleared 510(K)
- K834187JAKOBI SURG. INSTRUMENTS #6 502Cleared 510(K)
- K832996SURGICAL IOP MONITOR2Cleared 510(K)
- K813619CONPHAR-SCHIOETZ TONOMETER2Cleared 510(K)
- K781105TONOMETER, DIGITON2Cleared 510(K)
- K772130OCULAR CEREBRAL VASCULAR MONITOR2Cleared 510(K)
- HKZSterilizer, Tonometer1Product Code
- HLACalibrator, Tonometer2Product Code
- HLCInstrument, Measuring, Stereopsis1Product Code
- HLERuler, Nearpoint (Punctometer)1Product Code
- HLFDevice, Measuring, Lens Radius, Ophthalmic1Product Code
- HLGPupillometer, Ac-Powered1Product Code
- HLHPupillometer, Manual1Product Code
- HLIOphthalmoscope, Ac-Powered2Product Code
- HKMRetinoscope, Battery-Powered1Product Code
- HKNRefractor, Manual, Non-Powered, Including Phoropter1Product Code
- HKORefractometer, Ophthalmic1Product Code
- HKQPrism, Rotary, Ophthalmic1Product Code
- HKRLens, Maddox1Product Code
- HKSPrism, Gonioscopic1Product Code
- HKTPrism, Fresnel, Ophthalmic1Product Code
- HKWPrism, Bar, Ophthalmic1Product Code
- KYHEndoscope, Ophthalmic2Product Code
- MPAEndoilluminator2Product Code
- NKZEndoilluminator, Reprocessed2Product Code
- HITTester, Color Vision1Product Code
- HIWAnomaloscope1Product Code
- HIXMaxwell Spot, Ac-Powered1Product Code
- HIYBrush, Haidinger, (Including Macular Integrity)1Product Code
- HJAPhotokeratoscope1Product Code
- HJBInstrument, Measuring, Corneal Radius1Product Code
- HJCEsthesiometer, Ocular1Product Code
- HJDIlluminator, Color Vision Plate1Product Code
- HJILens, Fundus, Hruby, Diagnostic1Product Code
- HJJLens, Fresnel, Flexible, Diagnostic1Product Code
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic2Product Code
- HJLLens, Condensing, Diagnostic1Product Code
- HJMTransilluminator, Ac-Powered2Product Code
- HJNTransilluminator, Battery-Powered1Product Code
- HJOBiomicroscope, Slit-Lamp, Ac-Powered2Product Code
- HJQStereoscope, Ac-Powered1Product Code
- HJRStereoscope, Battery-Powered1Product Code
- HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)1Product Code
- HJTHaploscope1Product Code
- HJWAdaptometer (Biophotometer)1Product Code
- HKDTape, Nystagmus1Product Code
- HKFMirror, Headband, Ophthalmic1Product Code
- HKGFornixscope1Product Code
- HKICamera, Ophthalmic, Ac-Powered2Product Code
- HKLRetinoscope, Ac-Powered2Product Code
- HLJOphthalmoscope, Battery-Powered2Product Code
- HLKScreen, Tangent, Target, Battery-Powered1Product Code
- HLLMonitor, Eye Movement2Product Code
- HLMInstrument, Measuring, Lens, Ac-Powered1Product Code
- HLNGauge, Lens, Ophthalmic1Product Code
- HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)1Product Code
- HLPTarget, Fusion And Stereoscopic1Product Code
- HLQKeratoscope, Ac-Powered1Product Code
- HLRKeratoscope, Battery-Powered1Product Code
- HLSExophthalmometer1Product Code
- HLTPreamplifier, Ac-Powered, Ophthalmic2Product Code
- HLWPreamplifier, Battery-Powered, Ophthalmic2Product Code
- HLXPhotostimulator, Ac-Powered2Product Code
- HLZElectrode, Corneal2Product Code
- HMCMonitor, Eye Movement, Diagnostic2Product Code
- HMDChair, Ophthalmic, Manual1Product Code
- HMEChair, Ophthalmic, Ac-Powered1Product Code
- HMFStand, Instrument, Ac-Powered, Ophthalmic1Product Code
- HMGStand, Instrument, Ophthalmic, Non-Powered1Product Code
- HMHRack, Skiascopic1Product Code
- HMJScreen, Tangent, Projection, Battery-Powered1Product Code
- HMKEuthyscope, Ac-Powered2Product Code
- HMLEuthyscope, Battery-Powered1Product Code
- HMMDistometer1Product Code
- HOJScreen, Tangent, Target1Product Code
- HOKScreen, Tangent, Projection, Ac-Powered1Product Code
- HOLScreen, Tangent, Felt (Campimeter)1Product Code
- HOMScreen, Tangent, Ac-Powered (Campimeter)1Product Code
- HONPerimeter, Manual1Product Code
- HOOPerimeter, Ac-Powered1Product Code
- HOPCampimeter, Stereo, Battery-Powered1Product Code
- HOQGrid, Amsler1Product Code
- HORSimulatan (Including Crossed Cylinder)1Product Code
- HOSProjector, Ophthalmic1Product Code
- HOWDrum, Opticokinetic1Product Code
- HOXChart, Visual Acuity1Product Code
- HPAFrame, Trial, Ophthalmic1Product Code
- HPBClip, Lens, Trial, Ophthalmic1Product Code
- HPCSet, Lens, Trial, Ophthalmic1Product Code
- HPDLens, Bagolini1Product Code
- HPJInstrument, Visual Field, Laser2Product Code
- HPKTonograph2Product Code
- HPLDevice, Fixation, Ac-Powered, Ophthalmic1Product Code
- HPTPerimeter, Automatic, Ac-Powered1Product Code
- HPWProbe And Counter, Isotope, For Phosphorus 322Product Code
- HRECabinet, Instrument, Ac-Powered, Ophthalmic1Product Code
- HRIPupillograph1Product Code
- KYDStrip, Schirmer1Product Code
- MMFPhotorefractor2Product Code
- MMQTopographer, Corneal, Ac-Powered1Product Code
- MSGOphthalmoscopes, Replacement Batteries, Hand-Held2Product Code
- MXKDevice, Analysis, Anterior Segment2Product Code
- MYCOphthalmoscope, Laser, Scanning2Product Code
- NCFAberrometer, Ophthalmic1Product Code
- NFDSelector, Color, Spectacle, Lens, Tint1Product Code
- NJGFlasher, Afterimage, Ophthalmic2Product Code
- NJJTonometer, Analyzer, Ocular Blood Flow2Product Code
- NOGTopographer, Corneal, Battery Powered1Product Code
- NOHPhotokeratoscope, Battery Powered1Product Code
- NOIStand, Instrument, Ophthalmic, Battery Powered1Product Code
- NQEMicroscope, Specular2Product Code
- NXRFixation, Vision Training, Binocular1Product Code
- NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)2Product Code
- OBOTomography, Optical Coherence2Product Code
- OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation1Product Code
- PIBDiabetic Retinopathy Detection Device2Product Code
- PJZCamera, Ophthalmic, General-Use2Product Code
- PLZOcular Pattern Recorder2Product Code
- PMWStrabismus Detection Device2Product Code
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt2Product Code
- QERCamera, Ophthalmic, Slit-Scanning2Product Code
- NFFDevice, Storage, Images, Ophthalmic1Product Code
- NFGDevice, Communications, Images, Ophthalmic1Product Code
- NFHDigitizer, Images, Ophthalmic2Product Code
- NFIDevice, Hardcopy, Images, Ophthalmic2Product Code
- NFJSystem, Image Management, Ophthalmic2Product Code
- QTODigital Visual Acuity Test1Product Code
- QTWDigital Amsler Grid1Product Code
- QZPCamera, Ophthalmic, Non-Prescription2Product Code
- SBIManual Refractor, 3d Display1Product Code
- SBNDigital Therapy Device For Convergence Insufficiency1Product Code
- SCWDigital Prismatic Correction1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- 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
Icare ic100
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K153694
- 510(k) Type
- Traditional
- Applicant
- Icare Finland Oy
- Country
- Finland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/19/2016
- Days to Decision
- 118 days
- Submission Type
- Summary