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
- 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
- K142486HEINE BETA 200, HEINE BETA 200 S, HEINE K 1802Cleared 510(K)
- K142837HEINE SIGMA 250 & HEINE SIGMA 250 M22Cleared 510(K)
- K131959HEINE MINI 3000(R) OPHTHALMOSCOPE2Cleared 510(K)
- K131961HEINE BETA 200(R) OPHTHALMOSCOPE2Cleared 510(K)
- K131719OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS2Cleared 510(K)
- K123587HEINE MINI 3000 LED OPHTHALMOSCOPE2Cleared 510(K)
- K093495OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS2Cleared 510(K)
- K070270PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E362Cleared 510(K)
- K05259966 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A2Cleared 510(K)
- K061278OPTYSE OPHTHALMOSCOPE2Cleared 510(K)
- K053425PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS2Cleared 510(K)
- K032087KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-50042Cleared 510(K)
- K002044MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT2Cleared 510(K)
- K962767MS401097-17,MS722-K,MS720,MS721,MS7222Cleared 510(K)
- K970029KEELER SPECTRA INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K950914RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V2Cleared 510(K)
- K950797HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 1342Cleared 510(K)
- K950796HALOGEN DIAGNOSTIC SET BX A - 123452Cleared 510(K)
- K945640RI-SCOPE S OTOSCOPE2Cleared 510(K)
- K944402FOCOMETER2Cleared 510(K)
- K942719NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR2Cleared 510(K)
- K942721NEITZ HALOGEN OPHTHALMOSCOPE BXA-132Cleared 510(K)
- K942717NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A2Cleared 510(K)
- K942034R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 55022Cleared 510(K)
- K936104R & D BATTERIES2Cleared 510(K)
- K936018REPLACEMENT BATTERIES PART NO. 5098,5135, 50972Cleared 510(K)
- K925755DE LUXE2Cleared 510(K)
- K925756UNI II2Cleared 510(K)
- K932504RI-FORMER2Cleared 510(K)
- K925757OPHTHALMOSCOPE2Cleared 510(K)
- K923543MIS2Cleared 510(K)
- K922910MEDICAL BATTERY PACKS2Cleared 510(K)
- K920272ORIEL2Cleared 510(K)
- K896072D.L. SCOPE OPHTHALMOSCOPE2Cleared 510(K)
- K873987IRAS GLARE TESTER2Cleared 510(K)
- K871735VOROSCOPE(TM)2Cleared 510(K)
- K853891INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K852953#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD2Cleared 510(K)
- K852334MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)2Cleared 510(K)
- K843897POCKET OPHTHALMOSCOPE GH2Cleared 510(K)
- K842567PORTABLE ACUIOMETER2Cleared 510(K)
- K841292SPECTACLE INDIRECT OPHTHALMOSCOPE2Cleared 510(K)
- K832437MEDIC LUX DIAGNOSTIC SETS2Cleared 510(K)
- K830215DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP2Cleared 510(K)
- K780215EYESCOPE2Cleared 510(K)
- K760771SOLA SCHULTZE-CROCK OPTHALMOSCOPE2Cleared 510(K)
- K760770SOLA COMMIDO LOUPE2Cleared 510(K)
- 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
DE LUXE
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K925755
- 510(k) Type
- Traditional
- Applicant
- RUDOLF RIESTER GMBH & CO. KG
- Country
- Germany
- FDA Decision
- Substantially Equivalent - Kit
- Decision Date
- 12/3/1993
- Days to Decision
- 385 days
- Submission Type
- Statement