Part 886 Subpart B—Diagnostic Devices

FDA submissions for Part 886 Subpart B—Diagnostic Devices in the Ophthalmic (OP) review panel, including product codes and regulations.

Section range: §§ 886.1040–886.1945

CFR Part: 886

Product Codes

Product CodeDevice NameRegulationClassDevices
HJCEsthesiometer, Ocular886.104012
HJWAdaptometer (Biophotometer)886.105010
OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation886.105011
HIWAnomaloscope886.107013
HIYBrush, Haidinger, (Including Macular Integrity)886.109010
PIBDiabetic Retinopathy Detection Device886.110027
HKICamera, Ophthalmic, Ac-Powered886.11202156
MMFPhotorefractor886.112021
PJZCamera, Ophthalmic, General-Use886.112020
QERCamera, Ophthalmic, Slit-Scanning886.112023
QZPCamera, Ophthalmic, Non-Prescription886.112020
HMDChair, Ophthalmic, Manual886.114011
HMEChair, Ophthalmic, Ac-Powered886.1140116
HOXChart, Visual Acuity886.1150132
QTODigital Visual Acuity Test886.115011
HJDIlluminator, Color Vision Plate886.116011
NFDSelector, Color, Spectacle, Lens, Tint886.116011
HITTester, Color Vision886.117019
HMMDistometer886.119012
HOWDrum, Opticokinetic886.120011
HLZElectrode, Corneal886.1220211
HMKEuthyscope, Ac-Powered886.125020
HMLEuthyscope, Battery-Powered886.125010
HLSExophthalmometer886.127011
HPLDevice, Fixation, Ac-Powered, Ophthalmic886.129017
NXRFixation, Vision Training, Binocular886.129011
SBNDigital Therapy Device For Convergence Insufficiency886.129011
NJGFlasher, Afterimage, Ophthalmic886.130020
HKGFornixscope886.132010
HOQGrid, Amsler886.133018
QTWDigital Amsler Grid886.133011
HJTHaploscope886.134012
PMWStrabismus Detection Device886.134221
HJAPhotokeratoscope886.135015
HLQKeratoscope, Ac-Powered886.1350129
HLRKeratoscope, Battery-Powered886.135017
MMQTopographer, Corneal, Ac-Powered886.135015
NOGTopographer, Corneal, Battery Powered886.135010
NOHPhotokeratoscope, Battery Powered886.135010
HPJInstrument, Visual Field, Laser886.136025
HPDLens, Bagolini886.137510
HJLLens, Condensing, Diagnostic886.138011
HJKLens, Contact, Polymethylmethacrylate, Diagnostic886.1385241
NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)886.138521
HJJLens, Fresnel, Flexible, Diagnostic886.139010
HJILens, Fundus, Hruby, Diagnostic886.139518
HKRLens, Maddox886.140010
HPCSet, Lens, Trial, Ophthalmic886.1405113
HPBClip, Lens, Trial, Ophthalmic886.141010
HPAFrame, Trial, Ophthalmic886.141515
HLNGauge, Lens, Ophthalmic886.142012
HLMInstrument, Measuring, Lens, Ac-Powered886.1425116
HLFDevice, Measuring, Lens Radius, Ophthalmic886.143013
HIXMaxwell Spot, Ac-Powered886.143512
HJBInstrument, Measuring, Corneal Radius886.145015
HLCInstrument, Measuring, Stereopsis886.146010
HKFMirror, Headband, Ophthalmic886.150010
HLLMonitor, Eye Movement886.151024
HMCMonitor, Eye Movement, Diagnostic886.151021
HLIOphthalmoscope, Ac-Powered886.1570287
HLJOphthalmoscope, Battery-Powered886.1570247
MSGOphthalmoscopes, Replacement Batteries, Hand-Held886.157022
MYCOphthalmoscope, Laser, Scanning886.1570222
OBOTomography, Optical Coherence886.1570266
SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device886.160021
HONPerimeter, Manual886.160510
HOOPerimeter, Ac-Powered886.160516
HPTPerimeter, Automatic, Ac-Powered886.1605141
HLXPhotostimulator, Ac-Powered886.1630218
HLTPreamplifier, Ac-Powered, Ophthalmic886.164024
HLWPreamplifier, Battery-Powered, Ophthalmic886.164023
HKWPrism, Bar, Ophthalmic886.165012
HKTPrism, Fresnel, Ophthalmic886.165510
SCWDigital Prismatic Correction886.165512
HKSPrism, Gonioscopic886.1660110
HKQPrism, Rotary, Ophthalmic886.166510
HPWProbe And Counter, Isotope, For Phosphorus 32886.167020
HOSProjector, Ophthalmic886.168019
HRIPupillograph886.169010
HLGPupillometer, Ac-Powered886.170013
HLHPupillometer, Manual886.170012
HMHRack, Skiascopic886.175012
HKORefractometer, Ophthalmic886.1760135
NCFAberrometer, Ophthalmic886.176014
HKNRefractor, Manual, Non-Powered, Including Phoropter886.177013
SBIManual Refractor, 3d Display886.177011
HKLRetinoscope, Ac-Powered886.178026
HKMRetinoscope, Battery-Powered886.178017
HLERuler, Nearpoint (Punctometer)886.179010
KYDStrip, Schirmer886.180013
HLKScreen, Tangent, Target, Battery-Powered886.181010
HMJScreen, Tangent, Projection, Battery-Powered886.181012
HOJScreen, Tangent, Target886.181013
HOKScreen, Tangent, Projection, Ac-Powered886.181011
HOLScreen, Tangent, Felt (Campimeter)886.181010
HOMScreen, Tangent, Ac-Powered (Campimeter)886.181011
HOPCampimeter, Stereo, Battery-Powered886.181010
HORSimulatan (Including Crossed Cylinder)886.184011
HJOBiomicroscope, Slit-Lamp, Ac-Powered886.18502108
MXKDevice, Analysis, Anterior Segment886.1850223
NQEMicroscope, Specular886.185029
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt886.185020
HMFStand, Instrument, Ac-Powered, Ophthalmic886.1860115
HMGStand, Instrument, Ophthalmic, Non-Powered886.186014
HRECabinet, Instrument, Ac-Powered, Ophthalmic886.186010
NOIStand, Instrument, Ophthalmic, Battery Powered886.186010
HJQStereoscope, Ac-Powered886.187011
HJRStereoscope, Battery-Powered886.187010
HLPTarget, Fusion And Stereoscopic886.188013
HKDTape, Nystagmus886.190510
HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)886.191010
HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)886.191010
PLZOcular Pattern Recorder886.192521
HKXTonometer, Ac-Powered886.1930258
HKYTonometer, Manual886.1930256
HLACalibrator, Tonometer886.193020
HPKTonograph886.193020
NJJTonometer, Analyzer, Ocular Blood Flow886.193021
HKZSterilizer, Tonometer886.194010
HJMTransilluminator, Ac-Powered886.1945212
HJNTransilluminator, Battery-Powered886.194513
Innolitics

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